FDA News

Opportunity for an Ear Drop NDA

The FDA’s announcement this summer that it would take enforcement action against several unapproved formulations of ear drops provides a great opportunity for a pharmaceutical company that would like to develop an NDA for this type of product. Unapproved prescription... Read More

FDA Establishes Biosmilar Naming Convention

Last week, FDA announced the highly anticipated guidance, along with a proposed rule, which will establish a naming convention for biological products, including both related and biosimilar products. FDA states that a “shared proprietary names are not appropriate for all... Read More

FDA Guidance: Electronic Submission of ICSRs

On June 10, 2014, FDA published a final rule in the Federal Register, titled “Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements.” Among many things, this rule states that “certain postmarketing safety reports… be submitted to... Read More