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European regulators have turned down drugmakers’ requests to allow generic labeling of pandemic vaccines, which sponsors argue would help get their drugs to patients much sooner. Read More
When drugmakers change analytical validation methods during a drug’s lifecycle, the FDA says they should archive product samples to permit comparative studies of the old and new validation methods. Read More
Dynavax is withdrawing a European marketing authorization application for the Heplisav hepatitis B vaccine over concerns with adequate safety information. Read More
Chelsea Therapeutics’ orphan blood-pressure drug Northera won FDA approval Tuesday, following a rocky review path that included two advisory panel nods and a complete response letter. Read More
When submitting information to the FDA in electronic format, sponsors should not confuse the “receipt date” with the “submission date” when filing documents reflecting regulatory milestones such as INDs, NDAs, ANDAs, BLAs and master files, according to finalized agency guidance. Read More
Sponsors should prepare to submit information on their television marketing operations in an updated Module 1 electronic common technical documents (eCTD) format before the end of the year. Read More
The FDA has for a third time rejected Janssen and Bayer’s push to have their blockbuster blood-thinner Xarelto approved to treat patients with acute coronary syndrome (ACS). Read More
A drug to treat a rare congenital enzyme disorder developed by BioMarin Pharmaceutical became the first product approved by the FDA under its rare pediatric disease priority review voucher program. Read More