In a move that was not entirely unexpected, FDA delayed publication of a rule proposed last year that would allow generic drug sponsors to update safety warnings using the changes being effected (CBE) process. While the comment period had earlier been extended, there was no corresponding extension in the scheduled publication date of December 2014. In the meantime, FDA received well over 100 comments about the measure. In announcing the extension, the FDA spokeswoman noted that “FDA received a great deal of public input from various stakeholders during the comment period on the proposed rule. We are committed to reviewing and considering all of the comments received as we develop the final rule”. PDG will continue to keep our readers posted as events unfold.
PDG delivers strategic pharmaceutical and FDA regulatory consulting, scientific support and US pharmaceutical registration assistance spanning proof of concept through to commercialization. PDG’s integrated team of professionals have years of industry experience addressing FDA submission, approval and post-marketing assignments across a variety of dosage forms and therapeutic areas. Expertise spans prescription and nonprescription (OTC) drugs, both NDA and monograph. PDG was founded in 1999 by Dr. Cheryl Blume, is headquartered in Tampa, Florida, and provides regulatory consulting services to organizations of all sizes, both foreign and domestic. Click here to contact us.