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CCH NetNews™ |
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(October 13, 2009)
Food and Drug Law |
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Guidelines on adherence to postmarketing safety reporting requirements for combination products were provided to manufacturers in a proposal by the FDA. The proposal would clarify the postmarketing safety reporting requirements that apply when drugs, devices, and biological products are combined to create a combination product under a streamlined regulatory framework. The proposal would consolidate the repetitive requirements for each constituent part, including reporting death and serious adverse events, and allow reporting requirements associated with the type of marketing application under which the product was approved or cleared. FDA Proposal.
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A draft guidance describing the format and content of a proposed risk evaluation and mitigation strategy (REMS) was published by the FDA. Titled “Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications,” the draft guidance also includes: (1) the format and content of a proposed risk evaluation and mitigation strategy, including supporting documentation; (2 ) the content of assessments and proposed modifications of approved REMS; (3) identifiers to use on REMS documents, (4) and methods of communication with the FDA about a REMS. FDA Notice.
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The comment period for the public docket to obtain and share information on the implementation of the Family Smoking Prevention and Tobacco Control Act (Public Law 111-31, ¶2006) was extended to December 28, 2009, by the FDA. The Act granted the FDA new authority to regulate the manufacture, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors. The FDA is particularly interested in receiving comments on the actions that would increase the likelihood of reducing the incidence and prevalence of tobacco products use and protecting the public health. FDA Notice.
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Pharmaceutical firms may participate in a voluntary two-year pilot program for the evaluation of proposed proprietary names to be conducted by FDA’s Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research. The pilot program will enable participating pharmaceutical firms to evaluate proposed proprietary names and submit the data generated from those evaluations to the FDA for review, as outlined in the FDA concept paper titled PDUFA Pilot Project Proprietary Name Review.” FDA Notice.
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