jueves, 9 de febrero de 2017

FDA Updates for Health Professionals | OPPORTUNITIES FOR COMMENT / GUIDANCES

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OPPORTUNITIES FOR COMMENT / GUIDANCES

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Draft Guidance - Recommended Statement for Over-the-Counter Aspirin-Containing Drug Products Labeled With Cardiovascular Related Imagery

FDA announced the availability of a draft guidance for industry entitled “Recommended Statement for Over-the-Counter Aspirin-Containing Drug Products Labeled With Cardiovascular Related Imagery.” Aspirin is a common active ingredient in many prescription and OTC drug products. Most OTC aspirin drug products are currently marketed pursuant to the Tentative Final Monograph (TFM) for Internal Analgesic, Antipyretic, and Antirheumatic (IAAA) Drug Products (53 FR 46204, November 16, 1988) for the temporary relief of minor aches and pains associated with a cold, headache, backache, toothache, premenstrual and menstrual cramps; minor pain of arthritis; and reduction in fever. More information

Compounding and Repackaging of Radiopharmaceuticals By Outsourcing Facilities

This guidance sets forth the FDA’s policy regarding compounding and repackaging of Radiopharmaceuticals for human use by entities that are registered with FDA as outsourcing facilities under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act or the Act).  This guidance describes how FDA intends to apply section 503B of the FD&C Act to radiopharmaceuticals compounded by outsourcing facilities.  It also describes the conditions under which FDA does not intend to take action for violations of sections 505 and 502(f)(1) of the FD&C Act when an outsourcing facility repackages radiopharmaceuticals. More information

Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers

This guidance addresses questions and clarifies FDA’s expectations for annual reporting to FDA by prescription drug wholesale distributors (wholesale distributors) and third-party logistics providers (3PLs) as required under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as amended by the Drug Supply Chain Security Act of 2013 (DSCSA). FDA previously published a draft guidance for industry entitled DSCSA Implementation: Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers (Annual Reporting Draft guidance).This question-and-answer guidance supplements the 24 information in the Annual Reporting draft guidance by addressing questions and comments that FDA received about annual reporting publication of the Annual Reporting draft guidance. More information

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