• On 5 February 2009, FDA posted a list of guidances CDER is planning to develop during Calendar Year 2009: http://www.fda.gov/cder/guidance/CY09.pdf.
  • On 17 February 2009, FDA announced the availability of draft guidances based on the International Conference on Harmonisation’s (ICH) Technical Requirements for Registration of Pharmaceuticals for Human Use. Submit written or electronic comments to the following Dockets by 20 April 2009 (http://www.regulations.gov/search/index.jsp)
  • On 9 January 2009, FDA announced the availability of two additional ICH guidances:
    • Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 2: Test for Extractable Volume of Parenteral Preparations General Chapter, available at: http://www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2008-D-0081-gdl.pdf. The guidance provides the results of the ICH Q4B evaluation of the Test for Extractable Volume of Parenteral Preparations General Chapter harmonized text from each of the three pharmacopoeias (US, European, and Japanese) represented by the Pharmacopoeial Discussion Group (PDG). The guidance conveys recognition of the three pharmacopoeial methods by the three ICH regulatory regions and provides specific information regarding the recognition.
    • Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 3: Test for Particulate Contamination: Subvisible Particles General Chapter, available at: http://www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2007-D-0306-gdl.pdf. The guidance provides the results of the ICH Q4B evaluation of the Test for Particulate Contamination: Subvisible Particles General Chapter harmonized text from each of the three pharmacopoeias (US, European, and Japanese) represented by the PDG.

These guidances are intended to recognize the interchangeability between the local regional pharmacopoeias, thus avoiding redundant testing in favor of a common testing strategy in each regulatory region.

  • On 17 February 2009, FDA announced the availability of the source code and supporting technical documentation for the Phonetic Orthographic Computer Analysis (POCA) software program. POCA is an analytic tool designed to help identify drug and biologic names and medical terminology that are phonetically and orthographically similar to one another. POCA is one analytic tool that FDA uses to review proposed proprietary drug and biologic names. Requests for single copies of the POCA software should be submitted to the following e-mail address: pocasourcecoderequest@fda.hhs.gov.
  • On 13 February 2009 FDA announced reopening until 16 March 2009, the comment period for the draft guidance entitled Process Validation: General Principles and Practices, available at: http://www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2008-D-0559-gdl.pdf. FDA is taking this action in response to a request for an extension of the comment period, due to the holiday season, to allow interested persons sufficient time to review this draft guidance and submit comments.
  • On 21 January 2009, FDA announced the availability of a final guidance Guidance for Sponsors, Industry, Researchers, Investigators, and Food and Drug Administration Staff: Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions: Compliance with Section 402(j) of The Public Health Service Act, Added By Title VIII of The Food and Drug Administration Amendments Act of 2007, dated January 2009, available at: http://www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2008-D-0224-gdl.pdf. The guidance provides sponsors, industry, researchers, investigators, and FDA staff with the FDA's current thinking regarding the types of applications and submissions that sponsors, industry, researchers, and investigators submit to FDA and accompanying certifications as described in Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA).
  • On 16 January 2009, FDA announced the amendment of its regulations on the submission of bioequivalence data to require an ANDA applicant to submit data from all bioequivalence (BE) studies the applicant conducts on a drug product formulation submitted for approval. In the past, ANDA applicants have submitted BE studies demonstrating that a generic product meets bioequivalence criteria in order for FDA to approve the ANDA, but have not typically submitted additional BE studies conducted on the same drug product formulation, such as studies that do not show that the product meets these criteria. FDA is amending the regulation because it now believes that data from additional BE studies may be important in Agency’s determination of whether the proposed formulation is bioequivalent to the reference listed drug (RLD), and are relevant to Agency’s evaluation of ANDAs in general. In addition, such data will increase FDA’s understanding of how changes in components, composition, and methods of manufacture may affect product formulation performance. The final rule is available at: http://www.fda.gov/OHRMS/DOCKETS/98fr/E9-884.pdf. The rule is effective July 15, 2009.
  • On 16 January 2009, FDA issued the following three guidances designed to help ensure the safety of FDA-regulated products in the supply chain http://www.fda.gov/bbs/topics/NEWS/2009/NEW01945.html:
  • On 16 January 2009, FDA announced the availability of a final Guidance for Industry: Evidence- Based Review System for the Scientific Evaluation of Health Claims, available at: http://www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2007-D-0371-gdl.pdf. The guidance outlines FDA’s approach to the review of the scientific evidence for health claims that meet the significant scientific agreement standard (SSA) and qualified health claims.
  • On 15 January 2009, FDA announced the availability of a final guidance for industry Adverse Event Reporting--Improving Human Subject Protection, available at http://www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2007-D-0202-gdl.pdf. The guidance is intended to assist the research community in interpreting requirements for submitting reports of unanticipated problems, including certain adverse events reports, to institutional review boards (IRBs). FDA developed the guidance in response to concerns raised by the IRB community that increasingly large volumes of individual, unanalyzed adverse event reports are inhibiting, rather than enhancing, the ability of IRBs 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.
  • On 15 January 2009, FDA issued a final rule (available at: http://www.fda.gov/OHRMS/DOCKETS/98fr/E9-682.pdf) to require IRBs to register through a system maintained by HHS. The registration information includes contact information, the number of active protocols involving FDA-regulated products reviewed during the preceding 12 months, and a description of the types of FDA-regulated products involved in the protocols reviewed. The IRB registration requirements will make it easier for FDA to inspect IRBs and to convey information to IRBs. The rule is effective 14 July 2009. The effective date is necessary to allow refinement of the electronic registration system so that it corresponds to this final rule. All IRBs must comply with the initial registration requirement and, if necessary, make required revisions to their registrations by 14 September 2009.
  • On 13 January 2009, FDA announced the availability of a final guidance Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices, available at: http://www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2008-D-0053-gdl.pdf. The guidance provides drug, biologics, and device manufacturers with the agency's views on the distribution of medical journal articles and scientific or medical reference publications that discuss unapproved new uses for FDAapproved drugs or biologics or FDA-approved or cleared medical devices to healthcare professionals and healthcare entities.
  • On 13 January 2009, FDA announced on behalf of several members of the Interagency Working Group on Import Safety the availability of a draft guidance Good Importer Practices, (http://www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2009-D-0675-gdl.pdf.) The draft guidance document provides general recommendations to importers on possible practices and procedures they may follow to increase the likelihood the products they import are in compliance with applicable U.S. safety and security requirements. The recommendations provided are intended to promote and facilitate an assessment by importers of a product's life cycle so the importer may make sound decisions about how best to address the product's potential to cause harm and to facilitate compliance with U.S. requirements. Press release: http://www.fda.gov/bbs/topics/NEWS/2009/NEW01941.html
  • On 5 January 2009, FDA announced the availability of a final guidance Labeling OTC Human Drug Products--Questions and Answers, (http://www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2004-D-0437-gdl.pdf.) The guidance primarily discusses labeling questions that have been frequently asked by manufacturers, packers, and distributors relating to standardized content and format requirements. The labeling examples in the guidance show various format and content features and suggest how OTC drug monograph labeling information finalized before the new requirements can be converted to the new format. The guidance finalizes the draft guidance of the same name published January 13, 2005 (70 FR 2415).
  • On 5 January 2009, FDA announced the availability of a draft guidance Assay Migration Studies for In Vitro Diagnostic Devices, (http://www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2008-D-0642-gdl.pdf.) The draft guidance presents a least burdensome regulatory approach to gaining FDA approval of Class III or certain licensed in vitro diagnostic devices in cases when a previously approved assay is migrating (i.e., transitioning) to a New System for which the assay has not been previously approved or licensed. Submit comments to Docket FDA-2008-D-0642 by 6 April 2009 (http://www.regulations.gov/search/index.jsp).
  • On 2 January 2009, FDA updated the allowed terminology for structured product labeling (SPL). Among other changes, FDA removed several sections and codings and added a User Safety Warnings Section. For details, see http://www.fda.gov/oc/datacouncil/spl.html.
  • On 22 December, FDA extended the expiration date of compliance policy guide (CPG) Sec. 400.210 Radiofrequency Identification (RFID) Feasibility Studies and Pilot Programs for Drugs to December 31, 2010. http://www.fda.gov/OHRMS/DOCKETS/98fr/04d-0499-gdl0001.pdf.
  • FDA WITHDRAWALS
    • On 10 February 2009, FDA announced the immediate withdrawal of a direct final rule (http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-22829.pdf) amending its regulations to require that the holder of a new drug application (NDA) submit certain information regarding authorized generic drugs in an annual report to a central office in the agency. FDA is withdrawing the direct final rule because the agency received significant adverse comment.
    • Effective January 16, 2009, FDA withdrew the Guidance for Industry and FDA: Interim Evidence-Based Ranking System for Scientific Data that was issued on July 10, 2003.

EMEA

  • The EMEA Guideline on Development, Production, Characterisation And Specifications For Monoclonal Antibodies And Related Products (EMEA/CHMP/BWP/157653/2007) was adopted in December 2008 and is coming into effect July 2009. http://www.emea.europa.eu/pdfs/human/bwp/15765307enfin.pdf
  • EMEA released for public consultation:
  • On 22 January 2009, EMEA adopted Guideline on the Requirements for Clinical Documentation for Orally Inhaled Products (OIP) Including the Requirements For Demonstration of Therapeutic Equivalence Between Two Inhaled Products for Use In the Treatment of Asthma and Chronic Obstructive Pulmonary Disease (COPD) in Adults and for Use in the Treatment of Asthma in Children and Adolescents, available at: http://www.emea.europa.eu/pdfs/human/ewp/415100enfin.pdf The guideline is effective on 1 August 2009.