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The FDA cited a Glenmark Pharmaceuticals facility in Solan, India for failing to investigate discrepancies, inadequate complaint records and improper maintenance of quality data. Read More
The FDA continued to issue a larger number of complete response letters to generics manufacturers last month — dropping from a spike in October, but still higher than any single month in the previous fiscal year. Read More
The FDA finalized its guidance on drug advertisements, clarifying the legal requirements for companies in the placement of the product’s name — as well as its size, prominence and frequency in promotional labeling, and the juxtaposition between branded and active ingredient names. Read More
The FDA flagged three U.S. facilities for a variety of noncompliances observed by agency investigators during inspections, including issues with labeling, failure to properly handle complaints and reporting of adverse events. Read More