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Drugmakers should summarize medication errors that don’t result in adverse reactions in periodic safety update reports and in their risk-management plans, the European Medicines Agency says. Read More
The FDA’s Office of Pharmaceutical Quality is developing a new inspection protocol that will focus on expert investigator-developed questions and assessment practices. Read More
Teva is asking the U.S. Supreme Court to overturn a Pennsylvania state court ruling that would let individuals sue generics makers for failing to promptly update their labels in response to new safety concerns, a move some experts say directly contradicts federal statutes. Read More
A drug safety committee in the EU wants manufacturers of ibuprofen to update their labeling to warn patients of a slightly increased risk of cardiovascular death when the painkiller is taken in high doses. Read More
Drugmakers operating in New Zealand must begin creating safety signal management processes for every drug they distribute to satisfy the country’s drug regulators. Read More
The European Commission has updated its GMP guideline on process validation to reflect the EU’s current risk-based approach to managing quality systems over the entire lifecycle of a drug. Read More
Drugmakers exporting drugs from India must now include barcodes on all tertiary and secondary packaging. The policy, intended to assure the safety and effectiveness of therapies reaching patients in the U.S. and elsewhere, affects drugs made on or after April 1, 2015. Read More
Drugmakers in the EU will pay slightly lower fees starting this month, under an annual adjustment that reflects the inflation rate for the previous year Read More
The European Medicines Agency has rejected calls from industry to use biosimilar reference products from outside the EU unless they are justified using pharmacokinetic tests. Read More
A federal judge ordered the FDA to turn over all records concerning Otsuka’s Abilify sNDA to the U.S. district court in Maryland by April 13, saying the agency is attempting to delay litigation over exclusivity of the blockbuster antipsychotic. Read More