Simplifying Global Compliance
The FDA plans to tell drugmakers by the end of November how they should exchange data with supply chain partners to satisfy new federal track-and-trace requirements. Read More
After fielding nothing but complaints with its proposed generic drug safety labeling rule, the FDA is receiving rare support for the proposal from a coalition of patient groups that says it would give injured consumers a clear avenue for redress. Read More
FDA advisors want stronger warning language on labels for non-steroidal anti-inflammatory drugs, or NSAIDs, saying language added in 2005 is not strong enough and may lead doctors and patients to think there is no risk of cardiovascular (CV) blood clots in short term use of the drugs. Read More
The FDA and Indian Ministry of Health & Family Welfare will begin sharing information from quality inspections of drugmakers’ manufacturing facilities. Read More
Sponsors should prepare to submit information on their television marketing operations in an updated Module 1 electronic common technical documents (eCTD) format before the end of the year. Read More
The FDA is examining how drug manufacturers exchange transaction data with their business partners to see if data-gathering methods already in use could satisfy new federal track-and-trace requirements. Read More
When submitting information to the FDA in electronic format, sponsors should not confuse the “receipt date” with the “submission date” when filing documents reflecting regulatory milestones such as INDs, NDAs, ANDAs, BLAs and master files, according to finalized agency guidance. Read More
When drugmakers change analytical validation methods during a drug’s lifecycle, the FDA says they should archive product samples to permit comparative studies of the old and new validation methods. Read More
Generic drug giants Teva and Mylan are just some of the 13 companies tapped by the FDA to participate in its Secure Supply Chain Pilot Program, an initiative five years in the making that will grant the companies’ products expedited treatment when they enter the U.S. Read More
The FDA has upgraded the status of Hospira’s troubled Rocky Mount, N.C., manufacturing plant to allow it to begin using the facility to manufacture new products. Read More
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