- On 6 April 2007 FDA issued a press release unveiling a new Web page that will keep the public informed about the status of post-approval patient studies for certain recently approved medical devices. The website is available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma_pas.cfm. For more information, see the press release: http://www.fda.gov/bbs/topics/NEWS/2007/NEW01603.html.
- Pilot Project Participants Needed: CDER and CBER are seeking sponsors interested in participating in a pilot project to test the submission of case report form (CRF) data provided electronically in extensible markup language (XML) based on the Operational Data Model (ODM) developed by the Clinical Data Interchange Standards Consortium (CDISC). The pilot will test the ability of a new data format to support all review activity, which the current submission format is incapable of doing. Data supplied in ODM format by sponsors during the pilot project will not replace any regulatory requirements for submitting CRFs. FDA anticipates that a successful pilot will allow CDER and CBER to routinely accept CRFs from studies employing electronic data capture (EDC) in ODM format in marketing applications provided in electronic format.
- Submit written or electronic requests to participate in the pilot project by 10 September 2007. General comments on the pilot project are welcome at any time. See http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-4451.pdf for details.
- At a recent RAPS meeting on 30 March 2007, Mark Roh, FDA acting regional director for the Pacific Region, announced FDA regional offices and some laboratories will close this fall as part of a reorganization announced two years ago. Roh noted FDA, especially the Office of Regulatory Affairs, is going through a massive reorganization. In February 2005, FDA announced it was reorganizing as part of an effort to improve agency oversight and transparency. The transformation began in March 2006, "with a completely new reporting structure that will take place by October 1, 2007,'' he said. Roh noted the number of districts will decline from 20 districts to 16 and compliance branches will drop from 20 to 10. Seven of 13 laboratories will shut down, regional offices will close, and functions will merge under the new structure to be completed by the fiscal year 2008, which starts October 1, 2007. The changes include the San Juan, P.R., office being "fused" with the Florida office, and the merging of offices in Cincinnati and Detroit, Kansas and Denver, and New Jersey and Philadelphia, Roh said. The Los Angeles office will remain a stand-alone office while San Francisco and Seattle will merge.
- On 15 March 2007, FDA published a list of premarket approval applications (PMAs) that have been approved by CBER. The list is intended to inform the public of the availability through the Internet and the FDA's Division of Dockets Management of summaries of safety and effectiveness data of approved PMAs. The list is available at: http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-4677.pdf and through the CBER website at: http://www.fda.gov/cber/products.htm
- On 21 March 2007 CDRH posted updated information on their website regarding the Japan - U.S. "Harmonization by Doing" HBD Pilot Program Initiative, available at: http://www.fda.gov/cdrh/international/hbdpilot.html.
- Effective 2 March 2007, a memorandum of understanding (MOU) between FDA and the National Cancer Institute (NCI) established a formal collaboration between FDA and NCI regarding the creation of a common standards-based data repository to facilitate the electronic exchange and analysis of data from research studies on investigational drugs in a fully secure manner. A copy of the MOU is available at: http://www.fda.gov/OHRMS/DOCKETS/98fr/FDA-225-07-4301-mou0001.PDF.
New Guidelines and Rules
- The IPAC-RS Supplier Quality Control Working Group, which includes representatives from Orally Inhaled and Nasal Drug Product (OINDP) manufacturers and device component suppliers, has published its GMP Guideline for Suppliers of OINDP Components, available for purchase at http://www.ipacrs.com/supplier.html. The IPAC-RS GMP Guideline, which incorporates the PS 9000 and ISO 9001 Guidelines, addresses those areas of GMP critical to OINDP that are not sufficiently addressed by existing quality Guidelines. This includes topics such as change control, cleaning, and extractables. The IPAC-RS Guideline was developed in an effort to help build quality into OINDP; encourage quality through design rather than through testing; promote quality assessment early in the supply chain; and provide OINDP suppliers and manufacturers with harmonized standards for OINDP component quality. The Working Group is working to confirm with FDA the status of the IPAC-RS GMP Guideline.
- The IPAC-RS Supplier Quality Control and OINDP Materials Working Groups will cohost a Workshop on Extractables and GMP for Components of Inhalation and Nasal Drug Products on 24-25 September 2007 in Basel, Switzerland. The Workshop will address the expectations for extractables and GMP for OINDP components and materials, and is appropriate for OINDP manufacturers, their suppliers, and suppliers of base materials such as resins. See page 10 of this newsletter for more information. Details and a link to registration will be posted at: http://www.ipacrs.com/supplier.html.
- On 13 March 2007, FDA announced the availability of a final guidance Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests, available at http://www.fda.gov/OHRMS/DOCKETS/98fr/03d-0044-gdl0002.pdf. The guidance describes some statistically appropriate practices for reporting results from different studies evaluating diagnostic tests and identifies some common inappropriate practices. Special attention is given to describing a practice called discrepant resolution and its associated problems.
- On 19 March 2007, FDA amended its regulations to change the location of a section in an overthe- counter (OTC) drug monograph. This action is editorial in nature and is intended to improve the accuracy of the agency's regulations. The rule is effective 19 March 2007.
- FDA published the final monograph (FM) for cold, cough, allergy, bronchodilator, and antiasthmatic combination drug products for OTC human use in the Federal Register of December 23, 2002 (67 FR 78158 http://www.fda.gov/OHRMS/DOCKETS/98fr/02- 32158.pdf). In that FM, FDA inadvertently added Sec. 341.40 (21 CFR 341.40) to subpart C of the monograph, when that section should have been added to subpart B of the monograph. Accordingly, FDA is now moving Sec. 341.40 from subpart C to subpart B of the monograph.
- On 19 March 2007, FDA announced the availability of a draft guidance for industry Indexing Structured Product Labeling, available at http://www.fda.gov/OHRMS/DOCKETS/98fr/07d-0080- gdl0001.pdf. The guidance explains that CDER will index structured product labeling (SPL) in the product labeling for human drugs. The guidance also makes recommendations to industry on how to request a change to the indexing information in the SPL. Comments are due by 18 June 2007 to FDA Docket No. 2007D-0080 (http://www.fda.gov/dockets/ecomments).
- On 23 March 2007, FDA announced the availability of a draft document Guidance for the Public, FDA Advisory Committee Members, and FDA Staff: Procedures for Determining Conflict of Interest and Eligibility for Participation in FDA Advisory Committees available at http://www.fda.gov/OHRMS/DOCKETS/98fr/07d-0101-gdl0001.pdf. The draft guidance describes the factors and analyses that should be used in considering whether an advisory committee member has a potential conflict of interest and whether participation in a meeting is appropriate. The guidance is intended to help understand and implement FDA policy in applying the applicable statutory and regulatory requirements. The draft guidance, when finalized, will replace the guidance document entitled ``FDA Waiver Criteria 2000” (http://www.fda.gov/oc/advisory/conflictofinterest/intro.html). Comments are due by 21 May 2007 to FDA Docket No. 2007D-0101 (http://www.fda.gov/dockets/ecomments). A press release is available at: http://www.fda.gov/bbs/topics/NEWS/2007/NEW01591.html.
- On 27 March 2007, FDA announced the availability of the draft guidance Modifications to Devices Subject to Premarket Approval (PMA)--The PMA Supplement Decision-Making Process, available at http://www.fda.gov/OHRMS/DOCKETS/98fr/07d-0083-gdl0001.pdf The draft guidance is intended to help the regulated industry determine whether submitting a PMA supplement or other notification to FDA is required for class III devices subject to PMA. FDA developed the draft guidance to address modifications to device design, device labeling, and the device manufacturing process. The guidance also can be applied when a legally marketed class III device is the subject of a recall or field corrective action and the manufacturer needs to change the device to assure its safety and effectiveness. The draft guidance is intended to apply to the device portion of combination products such as drug/device or biologic/device combinations. The draft guidance is not final nor is it in effect at this time. Comments are due by 25 June 2007 to FDA Docket No. 2007D-0083 (http://www.fda.gov/dockets/ecomments).
- On 30 March 2007 FDA announced the availability of a draft guidance for industry and review staff Target Product Profile--A Strategic Development Process Tool, available at http://www.fda.gov/OHRMS/DOCKETS/98fr/07d-0089-gdl0001.pdf. The purpose of the guidance is to inform sponsors and the review staff in CDER of the availability and potential usefulness of a target product profile (TPP). A TPP can be prepared by a sponsor and then shared voluntarily with the appropriate FDA review staff to facilitate communication regarding a particular drug development program. The draft guidance describes the purposes of a TPP, provides guidance on how to complete a TPP, makes suggestions on how to best use a TPP, and relates case studies that demonstrate the potential usefulness of a TPP. Comments are due by 29 May 2007 to FDA Docket No. 2007D-0089 (http://www.fda.gov/dockets/ecomments).
- On 9 April 2007, FDA announced the availability of a draft guidance for industry Guidance for Clinical Investigators, Sponsors, and IRBs; Adverse Event Reporting-- Improving Human Subject Protection, available at http://www.fda.gov/OHRMS/DOCKETS/98fr/07d-0106-gdl0001.pdf. The guidance is intended to assist the research community in interpreting requirements for submitting reports of (IRB). FDA developed this draft guidance in response to concerns raised by the IRB community that increasingly large volumes of individual adverse event reports are inhibiting rather than enhancing IRBs' ability to adequately protect human subjects. The guidance provides recommendations to IRBs, sponsors, and investigators on improving the usefulness of the adverse event information submitted to IRBs. Comments are due by 8 June 2007 to FDA Docket No. 2007D-0106 (http://www.fda.gov/dockets/ecomments).
- On 9 April 2007, FDA announced the availability of a draft guidance for industry Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products-- Content and Format, available at http://www.fda.gov/OHRMS/DOCKETS/98fr/07d-0118-gdl0001.pdf. The draft guidance is one of a series of guidance documents intended to assist applicants in drafting prescription drug labeling in which prescribing information is clear and accessible and complying with the new requirements in the final rule on the content and format of labeling for prescription drug and biological products (71 FR 3922, January 24, 2006 http://www.fda.gov/OHRMS/DOCKETS/98fr/06-544.pdf). The draft guidance is intended to help applicants select information for inclusion in the ``Dosage and Administration'' section of labeling and to help them organize that information. Comments are due by 9 July 2007 to FDA Docket No. 2007D-0118 (http://www.fda.gov/dockets/ecomments).
- Comment Period on Post-Approval Changes Reopened: On 13 April 2007, FDA reopened until 18 May 2007, the comment period for a notice of public meeting that published in the Federal Register of January 5, 2007 (72 FR 574 http://www.fda.gov/OHRMS/DOCKETS/98fr/E6-22588.pdf). In the notice, FDA announced a February meeting to solicit input on issues that the agency should consider if it decides to propose revisions to its regulations regarding chemistry, manufacturing, and controls (CMC) supplements and other changes to approved marketing applications for human drugs. FDA is reopening the comment period in light of continued public interest in this topic.
Outside of FDA
- The initial phase of the public consultation period on RFID policy in Europe concluded with the release of a Communication at the CeBIT fair in Hannover on 15 March 2007. The Communication was accompanied with a Commission Staff Working Document containing the analysis of the online consultation which took place in 2006. In addition, the Communication will create an RFID Stakeholder Group to provide advice and assistance in developing a European policy position concerning RFID applications. The documents are available at the European Commission RFID website: http://ec.europa.eu/information_society/policy/rfid/index_en.htm.
- The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has issued a bulletin providing new guidance on reporting and disseminating information about adverse incidents involving medical devices. The guidance, Reporting Adverse Incidents and Disseminating Medical Device Alerts, replaces a January 2006 document, and is available at www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2025833&ssTargetNodeId=572. The bulletin provides information on what is a medical device, what constitutes an adverse event and when to report it, how to report incidents, what to do with devices involved in incidents and how the MHRA responds to and manages reports. It also addresses the dissemination of medical device alerts and field safety notices and corrective actions.
- The Secretary's Advisory Committee on Genetics, Health, and Society (SACGHS) is requesting public comment on a draft report Realizing the Promise of Pharmacogenomics: Opportunities and Challenges, available at http://www4.od.nih.gov/oba/sacghs/SACGHS_PGx_PCdraft.pdf. Comments are due by 1 June 2007. For more information see: http://www4.od.nih.gov/oba/sacghs/public_comments.htm.
- S. 484 Enhancing Drug Safety and Innovation Act of 2007 (aka: Kennedy Enzi Act) http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=110_cong_bills&docid=f:s484is.txt.pdf:)
- Amends the Federal Food, Drug, and Cosmetic Act to require an application for approval for a new drug or biological product to include a proposed risk evaluation and mitigation strategy, which must include: (1) labeling for the drug for use by health care providers; (2) submission of reports for the drug; and (3) a statement as to whether the analysis and surveillance are sufficient to assess the serious risks of the drug.
- Establishes a Drug Safety Oversight Board.
- Requires the Secretary of HHS to establish the Reagan-Udall Institute for Applied Biomedical Research as a nonprofit corporation to advance the Critical Path Initiative to modernize medical product development, accelerate innovation, and enhance product safety. Requires the Institute to have a Board of Directors. Allows the Board to coordinate and collaborate with other entities to conduct research, education, and outreach and to modernize the sciences of developing, manufacturing, and evaluating the safety and effectiveness of diagnostics, devices, biologics, and drugs.
- Amends the Public Health Service Act to require the Secretary, acting through the Director of the NIH, to establish and administer a clinical trial registry database and a clinical trial results database. Requires a responsible part for a clinical trial to submit clinical trial information to the Director for inclusion in the databases.
- Requires each individual under consideration for a term on an advisory committee providing advice or recommendations to the Secretary regarding FDA activities to disclose industry financial interests.
Status: Introduced 2/1/07; currently in Committee on Health, Education, Labor and Pensions 3/14/07 hearings held.
- S.1024 Safer Drug Assessment Technology Advancement Act or Safer DATA Act http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=110_cong_bills&docid=f:s1024is.txt.pdf
- A bill to improve the underlying science of drug safety decisionmaking and strengthen the ability of the Food and Drug Administration to assess, manage, and communicate drug safety information to patients and providers.
- Requires the FDA to act in collaboration with academic institutions and private entities to establish and validate an integrated post-market risk surveillance system within two years of enactment.
- Requires the development of an active surveillance infrastructure for the collection and reporting of data from patient records, providers, Medicare, VA health system, private databases, and other sources the Secretary deems necessary to create a robust system to identify serious adverse events and potential drug safety signals.
- Requires procedures to enable the post-market risk identification and analysis system to perform data mining activities and identify adverse event trends and patterns that need further analysis. Requires data be collected, monitored and reported in a timely, routine, and automatic manner.
- Establishes drug safety collaborations with academic institutions and other private entities with expertise in data analysis to provide top of the line data management and assessment and perform advanced research on identified safety risks.
- Private entities acting at the direction of the FDA will report results to the FDA to enhance the internal drug safety decision making process.
- Creates a comprehensive web-based portal for drug safety information on FDAapproved drugs on the market.
- Requires FDA to consolidate and maintain drug safety information currently found on a number of other government and private websites.
- Information posted would be comprehensive and include drug labeling, medication guides, patient packaging inserts, FDA drug safety alerts and guidance documents.
- The web portal would contain links to non-FDA websites containing relevant drug safety information such as medical journals and studies.
- The web portal would provide access to summaries of aggregate data collected from the active surveillance system to provide information of known and serious side effects.
- The FDA Advisory Committee on Communication shall regularly review the types of risk communication information provided on the web-portal to facilitate the efficient flow of information to patients and providers. Status: Introduced 3/29/07; currently in Committee on Health, Education, Labor and Pensions
Meetings of Interest Information from Recent Meetings
- Inhalation and Nasal Drugs: The Regulatory Landscape sponsored by the International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS), was held on 6-8 November 2006 in North Bethesda, MD. Presentations are posted at http://www.ipacrs.com/conf2006.html.
- The IPAC-RS Supplier Quality Control Working Group held its Second OINDP Component Supplier GMP Workshop on Wednesday, 14 February 2007 in Chicago, Illinois to introduce the Guideline and discuss its use with OINDP manufacturers and component suppliers. The Workshop was held in conjunction with the 13 February 2007 IPAC-RS Symposium on Extractables in Materials for OINDP, at which control of extractables in the OINDP supply chain was discussed. Presentations are available at http://www.ipacrs.com/supplier.html.
- The PQRI Leachables and Extractables Working Group held their second Training Course on Best Practices on 12-13 April 2007 in Chicago, Illinois. (presentations will be posted at: www.pqri.org)
Upcoming FDA Public Hearings/Meetings
- FDA is holding a public meeting Preparation for ICH Meetings in Brussels, Belgium on 3 May 2007 in Rockville, Maryland. (http://www.fda.gov/cder/meeting/ICH_20070406.htm). The topics to be discussed are the topics for discussion at the forthcoming ICH steering committee meeting. The purpose of the meeting is to solicit public input prior to the next steering committee and expert working groups meetings in Brussels, Belgium May 5-10, 2007, at which discussion of the topics underway and the future of ICH will continue. (Meeting was originally scheduled for 6 April.)
- FDA is holding a public meeting on 30 April 2007 (12:00 PM – 5:00 PM) to discuss the proposed recommendations for the reauthorization of the Medical Device User Fee and Modernization Act of 2002 (MDUFMA I) for fiscal years (FY) 2008 through 2012, as well as other proposals to improve the review of medical devices and the third party inspection program. The proposed recommendations were developed after discussions with the regulated industry. The public meeting and comment period will provide an opportunity for public input on the proposed recommendations from all interested parties, including the regulated industry, scientific and academic experts, healthcare professionals, and representatives of patient and consumer advocacy groups. Registration to attend and to present at the meeting must be received by 25 April 2007. Written comments are due by 18 May 2007 to FDA Docket No. 2007N-0068
(http://www.fda.gov/dockets/ecomments). For more details, see Federal Register notice:
http://www.fda.gov/OHRMS/DOCKETS/98fr/07-1919.pdf (corrected noticed published on 4/27/07:
http://www.fda.gov/OHRMS/DOCKETS/98fr/07n-0068-ncr0001.pdf) and press release:
- FDA is holding a public hearing on 27 April 2007 in Rockville, Maryland, to solicit views and information from interested parties concerning the concept of electronic distribution of FDA-approved prescribing information currently contained in the package insert (or PIs) for human prescription drug and biological products. In particular, FDA is seeking views and information on the feasibility of establishing a modern and efficient process for industry to electronically distribute prescribing information to dispensers. FDA is seeking input on a number of questions regarding the current use of package inserts and those logistical issues associated with electronic distribution of such prescribing information. See: http://www.fda.gov/OHRMS/DOCKETS/98fr/07-1604.pdf for details. · FDA Manufacturing Subcommittee of the Advisory Committee for Pharmaceutical Science and Clinical Pharmacology (formerly Advisory Committee for Pharmaceutical Science) on 30 April 2007 in Rockville, MD. (http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-3717.pdf) THIS MEETING WAS CANCELLED: http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-6283.pdf as was the meeting of the Advisory Committee for Pharmaceutical Science and Clinical Pharmacology meeting scheduled for 1-2 May. No rescheduling has been announced.
- FDA and Society of Clinical Research Associates (SoCRA) will hold a two-day workshop on FDA clinical trial statutory and regulatory requirements. The workshop for the clinical research community targets sponsors, monitors, clinical investigators, institutional review boards, and those who interact with them for the purpose of conducting FDA-regulated clinical research. The workshop will include both industry and FDA perspectives on proper conduct of clinical trials regulated by FDA. The Workshop will be held 16-17 May 2007 in Oakbrook, Illinois and 14-15 November 2007 in Honolulu, Hawaii (http://www.socra.org/html/FDA_Conference.htm)
- FDA's Center for Devices and Radiological Health and Office of Regulatory Affairs, in cooperation with AdvaMed's Medical Technology Learning Institute, is announcing a series of three seminars on FDA medical device regulations. These 2-day seminars, which are designed to address the training needs of start up and small device manufacturers and their suppliers, will include both industry and FDA perspectives and a question and answer period. 22-23 May 2007 in Lakewood, Colorado http://www.advamedmtli.org/mtli/denver.cfm); and 6-7 June 2007 in Pittsburgh, Pennsylvania (http://www.advamedmtli.org/mtli/pittsburgh.cfm).
- Workshop on BE, BCS and Beyond, co-sponsored by FDA and AAPS on 21-23 May 2007 in North Bethesda, Maryland (www.aapspharmaceutica.com/bebcs)
- FDA will hold the 10th Annual Educational Conference co-sponsored with the Orange County Regulatory Affairs Discussion Group (OCRA). The conference is intended to provide the Drug, Device, and Biologics industries with an opportunity to interact with FDA reviewers and compliance officers from the Centers and District Offices, as well as other industry experts. The main focus of this product areas. Industry speakers, interactive questions and answers, and workshop sessions will also be included to assure open exchange and dialogue on the relevant regulatory issues. The conference will be held on 11-12 June 2007 in Irvine, California. (http://www.ocradg. org/meetings.htm#educonf)
- FDA Public Hearing: Use of Medication Guides to Distribute Drug Risk Information to Patients on 12-13 June 2007 in Washington, DC (http://www.fda.gov/cder/meeting/medication_guides_200706.htm). Submit written or electronic notices of participation (registration) and comments for consideration at the hearing by 4:30 p.m. on May 12, 2007. Written or electronic comments will be accepted after the hearing until July 12, 2007. (Press release is available at: http://www.fda.gov/bbs/topics/NEWS/2007/NEW01606.html).
Other Upcoming Meetings
- Smi’s 3rd Annual Asthma & COPD Conference on 25-26 April 2007 in London, United Kingdom. (http://www.smi-online.co.uk/events/overview.asp?is=4&ref=2508)
- DIA will host Clinical Research & Product Registration of Biopharmaceuticals/Vaccines in India & China on 26-27 April 2007 in San Diego California (http://sacserv.com/tracking.jsp?linkid=82673&subid=5305960&campid=2004539&type=0)
- 4th Annual Advanced Initiatives in Medical Simulation (AIMS) Conference and Exhibition on 8- 9 May 2007 in Washington, DC. (http://www.medsim.org/)
- The 2nd Congress on Global Approaches to Risk Management throughout Product Life Cycles sponsored by FDA, Virginia Tech and AdvaMed, on 15-17 May 2007 in North Bethesda, MD. (http://www.advamedmtli.org/mtli/mtg07-08.cfm)
- 6th Annual European Drug Delivery Partnership 2007 on 15-16 May 2007 in Berlin, Germany (www.informa-ls.com/drugdelivery)
- 2nd Annual Drug Delivery 2007 on 6-8 June 2007 in San Diego, California. (http://www.pharmedassociates.com/conference.aspx?ccode=p666)
- E-08 Product Quality Lifecycle Implementation: Practical Approach to QbD - co-sponsored by the FDA and ISPE, 6-7 June 2007 in Arlington, Virginia. (http://www.ispe.org/cs/root/education_and_training/education_library/continuing_education/product_quality_lifecy cle_implementation_practical_approach_to_qbd).
- 16th International ISAM Congress sponsored by the International Society for Aerosols in Medicine (ISAM) on 16-20 June 2007 in Tours, France. (http://www.isam2007.com).
- 43rd Annual DIA Meeting on 17-21 June 2007 in Atlanta, Georgia. (http://www.diahome.org/DIAHome/FlagshipMeetings/home.aspx?meetingid=11362)
- 9th Annual FDA and the Current Challenges of GMPs on 23-25 July 2007 in New Brunswick, New Jersey (www.pharmaconference.com)
- Stability Testing to Support Global Markets sponsored by AAPS, EAS, PhRMA, GPhA and CHPA on 10-12 September 2007 in Bethesda, Maryland (http://www.aapspharmaceutica.com/meetings/meeting.asp?id=100)
- 2007 PDA/FDA Join Regulatory Conference Evolution of the Global Regulatory Environment: A Practical Approach to Change 24-28 September 2007 in Washington, DC (http://www.pda.org/webmodules/webarticles/templates/new_conferences_2007pdafda.aspx?articleid=923&z oneid=149)
- PQRI Training Course: Leachables and Extractables Best Practices on 26-27 September 2007in Basel Switzerland. http://www.pqri.org/workshops/leach_ext/pqrilandeworkshop.asp
- 11th Conference of the Global Harmonization Task Force on 3-4 October 2007 in Washington, DC (http://www.advamed.org/publicdocs/ghtf_oct_2007.html).
- DIA 5th Canadian Annual Meeting Blueprint for an Evolving Regulatory Environment on 28- 30 2007 in Ontario, Canada Call for Abstracts: deadline 11 June 2007 (http://www.diahome.org/DIAHome/resources/content.aspx?type=eopdf&file=%2fproductfiles%2f13920%2f07 019.pdf)
- PDA/FDA Co-Sponsored Conference Series on Quality Systems 1-2 November 2007 in Bethesda, Maryland, 10-11 December 2007 in Dublin, Ireland, Spring 2008 in China. (http://www.pda.org/webmodules/webarticles/templates/new_conferences_2007Qualsys.aspx?articleid=993& zoneid=157)
- DDL 18 (Drug Delivery to the Lungs 18) 12-14 December 2007 in Edinburgh, Scotland Call for Abstracts: Initial abstracts: 24 October 2007; Extended abstracts: 26 October 2007 (www.ddlconference. org.uk)
- DIA 20th Annual EuroMeeting 3-5 March 2008 in Barcelona Spain. Call for Presentation Abstracts: submittal deadline extended to 8 May 2007. (http://www.diahome.org/NR/rdonlyres/6E365713-629D-4471-9EC0- 6F2E3376F30D/0/Barcelona2008CallforAbstractsApr5.pdf)
- RDD 2008 Meeting 11-15 May 2008 in Scottsdale Arizona. (http://www.rddonline.com/conferences/rdd2008.asp)