- On 12 August 2009, FDA published two rules that seek to clarify the methods available to seriously ill patients interested in gaining access to investigational drugs and biologics when they are not eligible to participate in a clinical trial and don’t have other satisfactory treatment options. To support the effort to help these patients, the agency also is launching a new Web site (http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/AccesstoInvestigationalDrugs/default.htm) where patients and their health care professionals can learn about options for investigational drugs. The rules are effective on October 13, 2009.
- The two rules: Expanded Access to Investigational Drugs for Treatment Use and Charging for Investigational Drugs Under an Investigational New Drug Application are available at: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/InvestigationalNewDrugINDApplication/ucm172492.htm
- On 21 August 2009, FDA announced two proposed rules and a draft safety guidance that would require manufacturers of medical devices, drugs, and biologic products to report adverse postmarketing safety events electronically. FDA hopes that the new system will expedite review of safety data to identify potential product-related public health risks. Submit comments on all 3 documents by 19 November 2009 (http://www.regulations.gov/search/Regs/home.html#home).
- Guideline: eMDR—Electronic Medical Device Reporting http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM179471.pdf.
- Rules: Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements (http://edocket.access.gpo.gov/2009/pdf/E9-19682.pdf) and Medical Device Reporting: Electronic Submission Requirements (http://edocket.access.gpo.gov/2009/pdf/E9-19683.pdf)
- On 1 September 2009, FDA announced two final guidances intended to assist industry in complying with the labeling requirements for nonprescription and labeling requirements for dietary supplements.
- Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act: Questions and Answers http://edocket.access.gpo.gov/2009/pdf/E9-21093.pdf. In the final guidance FDA announced that it would not begin enforcing new labeling requirements for these products until September 2010. The new rules, which require manufacturers to provide contact information where patients can report adverse events, were enacted in 2007, but the agency will exercise enforcement discretion until next year.
- Guidance for Industry: Questions and Answers Regarding the Labeling of Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act. http://edocket.access.gpo.gov/2009/pdf/E9-21094.pdf
- On 8 September 2009, FDA announced the publication Modifications to the List of Recognized Standards, Recognition List Number: 022, available at: http://edocket.access.gpo.gov/2009/pdf/E9-21609.pdf. The publication contains modifications to the list of standards FDA recognizes for premarket reviews. The document is intended to assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.
- On 17 September 2009, FDA announced the draft guidance Microbiological Data for Systemic Antibacterial Drug Products – Development, Analysis, and Presentation, available at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM182288.pdf. The guidance provides industry with insight into FDA’s current thinking on types of microbiological studies, assessments, and clinical trials necessary to support an investigational new drug application (IND) and a new drug application (NDA). Submit comments to FDA Docket FDA-2009-D-0408 by 16 December 2009 (http://www.regulations.gov/search/Regs/home.html#home).
- On 21 September 2009, FDA announced the final guidance End-of-Phase 2A Meetings, available at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm079690.pdf. The guidance provides information on end-of-phase 2A (EOP2A) meetings for sponsors of investigational new drug applications (INDs). The guidance is intended to further FDA initiatives directed at identifying opportunities to facilitate the development of innovative medical products and improve the quality of drug applications through early meetings with sponsors.
- On 23 September 2009, FDA published a proposed rule Current Good Manufacturing Practice Requirements for Combination Products intended to codify current good manufacturing practice (cGMP) requirements for combination products, available at: http://edocket.access.gpo.gov/2009/pdf/E9-22850.pdf. The proposed rule seeks to clarify which cGMP requirements apply to different kinds of combination products, and describes a streamlined regulatory framework for demonstrating compliance. Submit comments to FDA Docket FDA-2009-N-0435 by 22 December 2009 (http:// www.regulations.gov/search/Regs/home.html#home).
- On 1 October 2009, FDA released a proposed rule to amend the combination product regulations concerning postmarket safety reporting. Specifically, the rule will seek to promote public health by increasing consistency of postmarket safety reporting for drugs, devices, and biological products that are combined to create a combination product. The proposed rule is available at: http://edocket.access.gpo.gov/2009/pdf/E9-23519.pdf. On 10 November the commenting period was extended to 5 February 2010. Submit comments to FDA Docket FDA-2008-N-0424 (http://www.regulations.gov/search/Regs/home.html#home
- On 1 October 2009, FDA announced the draft guidance for industry Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications, available at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM184128.pdf. The draft guidance describes the format and content of a proposed risk evaluation and mitigation strategy, including REMS supporting documentation, the content of assessments and proposed modifications of approved REMS, what identifiers to use on REMS documents, and how to communicate with FDA about a REMS. Submit comments to FDA Docket FDA- 2009-D-0461 by 30 December 2009 (http://www.regulations.gov/search/Regs/home.html#home).
- On 5 October 2009, FDA announced the draft guidance The Scope of the Prohibition Against Marketing a Tobacco Product in Combination with Another Article or Product Regulated under the Federal Food, Drug, and Cosmetic Act, available at: http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/ucm184283.htm. The guidance discusses certain activities that FDA believes do or do not fall within the scope of the prohibition, but it is not intended to provide an exhaustive analysis.
- On 8 October 2009, FDA announced the availability of a final guidance Implementation of Medical Device Establishment Registration and Device Listing Requirements Established by the Food and Drug Administration Amendments Act of 2007, available at: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM185877.pdf. The guidance explains recent changes in requirements and describes relevant information that device establishments must submit.
- On 19 October 2009, FDA announced the availability of a final guidance Labeling for Human Prescription Drug and Biological Products—Determining Established Pharmacologic Class for Use in the Highlights of Prescribing Information, available at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM186607.pdf. The guidance is intended to provide applicants and review staff with a definition of established pharmacologic class and to help them identify the most appropriate word (term) or phrase that describes the established pharmacologic class for a drug or biological product for inclusion in the Indications and Usage section of Highlights of Prescribing Information of approved labeling. The guidance finalizes the draft guidance published in the Federal Register on May 16, 2007.
- On 26 October 2009, FDA announced the availability of a final guidance Investigator Responsibilities— Protecting the Rights, Safety, and Welfare of Study Subjects, available at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM187772.pdf. The guidance is intended to assist investigators in meeting their responsibilities with respect to protecting human subjects and ensuring the integrity of data in the conduct of clinical investigations. The guidance also clarifies FDA’s expectations concerning the investigator’s responsibility for supervising a clinical study in which some study tasks are delegated to employees of the investigator or to outside parties.
- On 28 October 2009, FDA announced the availability of a draft guidance SPL (Structured Product Labeling) Standard for Content of Labeling Technical Qs & As, available at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM072392.pdf. The guidance assists sponsors who submit the content of their product labeling in SPL format to CDER and CBER. Submit comments to FDA Docket FDA-2009-D-0355 by 28 December 2009 (http://www.regulations.gov/search/Regs/home.html#home)
- On 29 October 2009, FDA announced a final rule technical amendment to its investigational new drug application (IND) regulations. INDs for in vivo bioavailability and bioequivalence studies in humans designed to support abbreviated new drug applications (ANDA) should now be submitted directly to the Office of Generic Drugs. The rule is effective October 29, 2009. See http://edocket.access.gpo.gov/2009/pdf/E9-26095.pdf for more details.
- On 10 November 2009, FDA released a draft guidance document E7 Studies in Support of Special Populations: Geriatrics; Questions & Answers, available at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM189544.pdf. The draft questions and answers (Q&A) guidance addresses the representation of geriatric patients in the clinical database, including representation of special characteristics of the geriatric patient population. The Q&As are intended to provide guidance on this issue. Submit comments to FDA Docket FDA-2009-D-0528 by 11 January 2010 (http://www.regulations.gov/search/Regs/home.html#home)
- The EMEA released the CHMP Pharmacovigilance Working Party Work Programme 2010. For more information see: http://www.emea.europa.eu/pdfs/human/phvwp/phvwpworkprogramme.pdf.
- The EMEA released the Work Plan for the Efficacy Working Party (EWP) 2010. For more information see: http://www.emea.europa.eu/pdfs/human/ewp/ewpworkprogramme.pdf.
- CHMP Efficacy Working Party Therapeutic Subgroup on Pharmacokinetics (EWP-PK) released the “Questions & Answers: Positions on specific questions addressed to the EWP therapeutic subgroup on Pharmacokinetics”, available at: http://www.emea.europa.eu/pdfs/human/ewp/61860408en.pdf.
- The GHFT released the Medical Devices: Post Market Surveillance: National Competent Authority Report Exchange Criteria and Report Form, available at: http://www.fdanews.com/ext/files/SG2-N79-R11.pdf.
- ISO 20072:2009 Aerosol drug delivery device design verification - Requirements and test methods http://www.iso.org/iso/catalogue_detail.htm?csnumber=41989