FDA Is Eliminating Regulations? Here’s One that Makes Sense!

The FDA has announced a proposed rule to repeal its regulation requiring any drug product that uses irradiation to be approved under an NDA or ANDA.  The Notice states that “this action is part of FDA’s implementation of Executive Orders (EOs) 13771 and 13777.  Under these EOs, FDA is comprehensively reviewing existing regulations to identify opportunities for repeal,

August Official Approvals and Receipts Released as OGD Approaches Record Year

The Office of Generic Drugs (OGD) released its official approval and receipt numbers late yesterday.  August saw 53 full approvals and 15 tentative approvals, leaving OGD 44 ANDA full approvals away from matching their previous FY record of 763 from FY 2017.  These approvals are quite an accomplishment given the fact that the slowdown in the first few months of calendar year 2018 was so drastic.

No Easy Solutions for Complex Generics Yet

The Complex Generic Drug Development Workshop is currently being held in Silver Spring, Maryland September 12‑13, 2018.  In her keynote address at the FDA’s Small Business and Industry Assistance (SBIA) workshop on complex generic drug development, Kathleen Cook Uhl stated that complex drug products are critical to the care of many serious medical conditions, such as multiple sclerosis,

Get Your Priorities Straight

The GRx+Biosims Conference held at Baltimore, MD from September 5-7, had a panel discussion regarding Successfully Managing Priority Generic Submissions on September 6th. The panel members were representatives from the industry.

Discussions centered around the experience with priority submissions in the first year of GDUFA II. The consensus was that the submission of PFC (pre-submission facility correspondence) related to the priority submissions were labor intensive.