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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
New data collection methods show more trials than previously thought need to meet their postmarketing requirements (PMR) and postmarketing commitments (PMC), a new FDA report says. Read More
After fielding nothing but complaints with its proposed generic drug safety labeling rule, the FDA is receiving rare support for the proposal from a coalition of patient groups that says it would give injured consumers a clear avenue for redress. Read More
BI subsidiary Ben Venue is recalling a lot of acetylcysteine 10 percent USP, after a single glass particle was seen in a single vial of the drug. Read More
Swiss drug giant Novartis has bought Cambridge, Mass.-based CoStim Pharmaceuticals in a bid to gain access to CoStim’s cancer immunotherapy platform. Read More
India will no longer allow the importation of drugs that have used up more than 40 percent of their shelf life, India’s Central Drugs Standard Control Organization (CDSCO) said Thursday. Read More
In another blow to Aveo’s oncology pipeline, Astellas announced it is ending a global partnership with the company to develop its troubled cancer drug tivozanib by August 11. 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