Alcohol, Tobacco, Firearms, and Explosives Bureau September 2, 2015 – Federal Register Recent Federal Regulation Documents
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Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Safety Labeling Changes-Implementation of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the requirement to make safety related labeling changes based upon new safety information that becomes available after the drug or biological product is approved under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) or the Public Health Service Act (PHS Act.)
Food and Drug Administration/Drug Information Association Oligonucleotide-Based Therapeutics Conference 2015
The Food and Drug Administration's (FDA's) Center for Drug Evaluation and Research, in cosponsorship with the Drug Information Association (DIA), is announcing a meeting entitled ``FDA/DIA Oligonucleotide-Based Therapeutics Conference 2015'' (FDA/DIA 2015 conference). The purpose of the meeting is to discuss advances, safety, and challenges in the field of oligonucleotide-based therapeutics.
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