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The FDA is voicing new safety concerns with the next-generation heart drugs known as PCSK9 inhibitors, asking drugmakers to flag any neurocognitive adverse events associated with the class of drugs. Read More
The European Medicines Agency (EMA) is calling on EU makers of seasonal influenza vaccines to develop enhanced safety signal monitoring systems that identify increases in allergic reactions, moving away from systems that simply check for specific batch deviations. Read More
Drug safety assessors in the EU are urging tougher restrictions on drugs containing domperidone used in anti-vomiting treatments such as Janssen’s Motilium, due to potential heart risks. Read More
Pfizer is recalling three lots of drug products after a packaging mix-up led to a capsule of the wrong drug product in a bottle of an antidepressant. Read More
The FDA will create a pharma-only enforcement unit that promises more consistent inspections and enforcement decisions with fewer bureaucratic hurdles for investigators to issue warning letters. Read More
The FDA and European Medicines Agency (EMA) have launched a new information-sharing initiative they hope will coordinate and speed international responses to drug safety problems. Read More
Concerns with particulates in injectable drugs is plaguing Agila Specialties again as the Mylan unit Feb. 19 revealed that its Polish plant is at the center of a recall of an anesthetic product. Read More
Porcine trypsin (PTy), a starting material used in biologic drugs, should be tested just after it is produced to ensure material from a single infected pig doesn’t enter production batches, EU regulators say. Read More
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