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The FDA will require large compounding pharmacies to register each year, pay a $15,000 annual fee and report a detailed list of all the products they manufacture every six months. Read More
The FDA has warned two Florida-based compounders, one for repeatedly making drugs without a prescription and another for more than 30 adverse events connected to its products. Read More
An HHS watchdog will audit how the FDA inspects generics manufacturing facilities, oversees postmarketing studies and ensures compliance with clinical trial reporting requirements, as well as how the drug industry is implementing the track-and-trace law. Read More
FDA investigators will be able to photograph most areas of a facility during an inspection, including product labels and visible contamination of materials, according to a final guidance issued last month. Read More
The FDA has slapped another Indian active pharmaceutical ingredient maker with a warning for data integrity weaknesses, including printing batch records from personal computers over which the company lacked adequate controls. Read More
The FDA has cited Cadila Pharmaceuticals for poor data integrity practices and sloppy investigations into foul smelling batches of active pharmaceutical ingredients (APIs), violations that the agency threatened could result in an import alert. Read More
The FDA has slapped another Indian active pharmaceutical ingredient maker with a warning for data integrity weaknesses, including printing batch records from personal computers over which the company lacked adequate controls. Read More
The FDA has cited Cadila Pharmaceuticals for poor data integrity practices and sloppy investigations into foul smelling batches of active pharmaceutical ingredients (APIs), violations that the agency threatened could result in an import alert. Read More
Drugmakers participating in an ISPE pilot program on quality metrics received new guidance on what data they need to collect, information that could provide a glimpse of the kinds of data that the FDA will start collecting next fall. Read More
An HHS watchdog will audit how the FDA inspects generics manufacturing facilities, oversees postmarketing studies and ensures compliance with clinical trial reporting requirements, as well as how the drug industry is implementing the track-and-trace law. Read More
Drugmakers participating in an ISPE pilot program on quality metrics received new guidance on what data they need to collect, information that could provide a glimpse of the kinds of data that the FDA will start collecting next fall. Read More