CDER issues a MAPP on responsibilities and procedures for developing some REMS.
FDA approves a Grifols PMA for the Procleix Babesia assay, a qualitative assay for detecting ribosomal RNA from four Babesia species (B. microti, B. d...
Vanda Pharmaceuticals files a complaint against FDA in DC federal court seeking to remove a partial clinical hold the agency illegally imposed prohibi...
Stakeholders question an FDA proposal to conduct research into the relationship between disease awareness and product-specific television ads.
FDA approves a new indication for Medtronics Pipeline Flex embolization device.
The International Conference on Harmonization outlines roles an informal discussion group on generic drugs will play to explore harmonization of scien...
FDA updates medical device reports on the risk of breast implant associated-anaplastic large cell lymphoma associated with all forms of breast implant...
CDER director Janet Woodcock says the Center will implement a new multidisciplinary team NDA and BLA regulatory approval program in this fiscal year.