The Federal Register’s (FR) pre-publication page today contained an interesting proposed renewal for the collection of information for Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution (here). The notice states that: Establishment registration information helps FDA identify who is manufacturing, repacking, relabeling, and salvaging drugs and where those operations are performed. […]
The Fourth Annual Global Regulatory Affairs CMC Conference was held in Philadelphia on October 29‑30, 2018. The conference focused on successful developmental and post-market CMC operations and product lifecycle management tactics, based on better understanding of U.S. and global regulatory requirements for small molecules and biologics. Talking of life -cycle management, the current draft of […]
LCS’ CEO, Fran Zipp, was interviewed by Economic Times during a meeting of the ISPE India affiliate. Click here for the full interview.
Although the Office of Generic Drugs (OGD) has not yet released the official approval numbers for October 2018 (which is the first month of FY 2019, and the first month of GDUFA II), it appears that a new record will be set. OGD approved 101 ANDAs, and tentatively approved 21 ANDAs for a total of […]
