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Compounding pharmacies have flooded the FDA with hundreds of comments seeking to protect access to bulk drug substances they use to make products. Read More
Beginning on June 16, whenever a drugmaker receives approval for a new drug by an EU member state, it will have 15 calendar days to report the approval to the EMA’s new centralized electronic registry. Read More
The FDA is telling drugmakers not to file supplemental applications for minor postapproval manufacturing changes such as swapping excipient suppliers, moving a manufacturing process within a plant or removing coloring or flavoring ingredients from a drug. Read More
Ben Venue is working with the FDA on a recall of its acetylcysteine solution 10 percent USP after a single glass particle was found in just one vial of a lot of the drug, the company said last month. Read More
The UK’s Medicines and Healthcare products Regulatory Agency (MRHA) is reminding drugmakers they must report all defects in medicinal products that could lead to a recall immediately upon discovery and provide regular updates on internal investigations into the defects. Read More
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
A control laboratory testing facility in Mumbai, India, has come under fire from the FDA after a summer inspection last year raised serious concerns about the quality of drugs tested there. Read More
Troubled drug compounder and repackager Medisca has landed in hot water with the FDA again after the agency found a different type of drug in recalled lots of L-citrulline. Read More
Novartis is recalling more than 200 lots of OTC cold and flu drugs distributed in seven countries — a massive market correction by the company beset with quality problems at its OTC plants since 2012. Read More
The FDA is expanding the types of documents that drugmakers can distribute to physicians that discuss off-label drug uses, loosening its limits on clinical practice guidelines (CPGs) and medical textbooks. Read More