Proposed Collection; 60-day Comment Request: A Generic Submission for Formative Research, Pretesting and Customer Satisfaction of NCI's Communication and Education Resources (NCI)
In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Institutes of Health, National Cancer Institute (NCI) will publish periodic summaries of propose projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Risk Evaluation and Mitigation Strategy: The Food and Drug Administration's Application of Statutory Factors in Determining When a Risk Evaluation and Mitigation Strategy Is Necessary; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Risk Evaluation and Mitigation Strategy: FDA's Application of Statutory Factors in Determining When a Risk Evaluation and Mitigation Strategy Is Necessary.'' This guidance is intended to clarify how FDA applies the factors set forth in the Federal Food, Drug, and Cosmetic Act (FD&C Act) in determining whether a risk evaluation and mitigation strategy (REMS) is necessary to ensure that the benefits of a drug outweigh its risks. This guidance is one of several developed to fulfill performance goals that FDA agreed to satisfy in the reauthorization of the prescription drug user fee program (the Prescription Drug User Fee Act (PDUFA) V). This guidance finalizes the draft guidance entitled ``FDA's Application of Statutory Factors in Determining When a REMS Is Necessary,'' issued September 21, 2016.
Determination That ANTIVERT Chewable Tablets, 25 Milligrams, and Tablets, 12.5 Milligrams, 25 Milligrams, and 50 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA or Agency) has determined that ANTIVERT (meclizine hydrochloride) chewable tablets, 25 milligrams (mg), and tablets, 12.5 mg, 25 mg, and 50 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.