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The FDA plans to discontinue accepting paper submissions from drugmakers submitting promotional materials for prescription drugs and offers guidance on how to submit such information using the electronic common technical document. Read More
European regulators are looking to industry for suggestions on the best ways to get generic versions of topical drugs approved without having to conduct time-consuming and expensive clinical trials to prove bioequivalence. Read More
Biosimilars manufacturers are looking to the FDA for official guidance on several aspects of regulation, including naming and interchangeability. Read More
As Otsuka’s exclusivity protection for its blockbuster Tourette syndrome drug Abilify expired Monday, the FDA urged a federal judge not to grant the drugmaker’s last-ditch request for a court order blocking the agency from approving generic versions of the drug. Read More
Homeopathic drugs could face greater regulatory scrutiny by the FDA, as the agency weighs whether its existing regulations and enforcement policies are sufficient to deal with the dramatic uptick in natural products on the U.S. market. Read More
With the Prescription Drug User Fee Act set to expire in September 2017, the FDA will kick into full gear on reauthorization negotiations this June, FDA Acting Commissioner Stephen Ostroff said Monday. Read More
The FDA is taking the unusual step of pressing Genervon Biopharmaceuticals to release all data from a Phase IIa trial of its amyotrophic lateral sclerosis drug, including an analysis of changes in patients’ lung function. Read More
An Indian pharmacists group is urging the government to immediately require detailed instructions on storage temperatures on all drug labels, to prevent improper handling in the supply chain and by end users. Read More
A global regulatory group is following the EU’s lead in recommending that drugmakers use a risk-management approach to qualify and validate manufacturing processes. Read More