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European regulators are establishing a task force that will advise on planning, developing, implementing and maintaining international standards on drug product identification. Read More
Drugmakers seeking approval of genetically engineered products must begin submitting an assessment with their applications that evaluates whether they would be harmful if released into the environment. Read More
Drugmakers may use pharmacokinetic bioequivalence studies to compare how two orally-inhaled drugs with the same active substance disperse in the lungs, the European Medicines Agency says. Read More
An EU-level court has established a precedent that would allow drugmakers to protect orphan drugs from generic competition by developing and patenting a similar drug for the same orphan indications while the original therapy still enjoys market exclusivity. Read More
Biologics makers should file their lot distribution reports using the same electronic messaging standard as is used for drug registration and labeling content of BLAs, FDA final guidance says. Read More
The FDA and Department of Justice are pursuing prosecutions of several international drugmakers for serious manufacturing quality violations, underscoring the agency’s increasing tendency to treat quality violations as fraud. Read More
Advocacy group Public Citizen is urging the FDA to pull oral forms of the antifungal drug ketoconazole from U.S. shelves due to serious health risks. Read More
The drug pricing authority in India published a compilation of the price caps for 509 drugs, effective this past Jan. 31, to give drugmakers a single source of pricing information. Read More