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The FDA is giving industry and other interested parties another 30 days to weigh in on its request for suggestions on new biomarkers to speed drug development, according to an FDA notice. 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
Makers of branded opioid pain relievers that want to claim their drugs are resistant to abuse must, in most cases, subject their products to three forms of tests to show the FDA how effectively they prevent misuse. Read More
The European Medicines Agency is revising the way drugmakers conduct studies for drugs to treat blood clots, for the first time separating out the clinical requirements for different types of clots. Read More
Consumer and patient advocacy groups made their case March 26 for the FDA’s proposed rule to give labeling parity to generic makers, one day ahead of an FDA public hearing to again solicit comment on the plan. Read More
The FDA continues to look into improving generic bioequivalence testing, sponsoring research into BE evaluation of drugs for which doctors are most likely to resist substituting a generic, such as anticoagulants. 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
Sun Pharma completed its $4 billion purchase of fellow Indian generics maker Ranbaxy March 25, shortly after the FTC signed off on a divestiture order allowing the merger as long as the companies relinquish rights to the antibiotic minocycline. Read More
Drugmakers sparred with consumer and patient advocates at a March 27 public hearing on the FDA’s proposed rule to give generics makers the ability to update label safety information independently — with generics firms opposing the rule and advocacy groups supporting it. Read More