The US FDA just released their Guidance for Industry titled “E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1)” (here). The guidance provides a path forward for the mutual acceptance of clinical trial data across regulatory authorities from Canada, the European Union, Japan, Switzerland, and the United States. The guidance clearly identifies the added revisions, […]
Getting back to the elemental impurities (EI) issue, we received additional interesting feedback from one ANDA sponsor. They said sometimes “this stuff gets tricky.” The sponsor related a situation of a capsule ANDA product that could be administered multiple times a day at high maximum daily dose. The empty capsule shell had the standard limit […]
As the compounding Industry awaits the next round of Guidances from FDA on using bulk drug substances, one point of controversy appears to be the fairness of compounding for 503A and 503B entities. The most recent Guidances for Compounding from Bulk Drug Substances are: Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A […]
After my post on Thursday (here) regarding the slowdown in ANDA approvals because of lack of documentation of elemental impurities, and my assumption relative to NDA applicants, I received some interesting feedback from two NDA applicants. I was told that the New Drug Division would not hold up issuing an approval action letter if the […]
Just days after FDA Commissioner Dr. Scott Gottlieb shared the 2018 Compounding Policy Priorities Plan, FDA issued three guidances: (1) Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act ; (2) Compounded Drug Products That Are Essentially Copies of Approved Drug […]
There is a big buzz about a new player in town but not a lot of information on how it plans to operate. Drug Store News reports “There will soon be a new generics manufacturer to contend with — one that comes with a built-in base of 450 hospitals. Four major health systems — Salt […]
FDA listed 106, either new or draft and/or revised draft guidances that it plans to issue in CY 2018. This is quite an ambitious agenda! This is a yearly exercise that FDA does and they have a tendency to come close to meeting their projections; be sure to review the entire list (here) to see […]
Here it is, 11 days into January 2018, and so far this month (at least at the last check this morning) OGD had approved only two ANDAs. Could it be that they pushed so many out in the first quarter of FY 2018 that there were none left to cross the finish line in early […]
The proverbial title of a 1962 hit song by Petula Clark is something that piqued my curiosity today. And yes, I am that old (I was 13 when that song came out and I loved to play with my pet dinosaur). Anyway, I digress! The reason I bring up “Never on Sunday” is, because, as […]
Here we are, at the end of another busy year. As a matter of fact, this blog is celebrating its 5th year of missives that we hope have provided you a different perspective into the world of FDA, along with some laughs along the way. It has been a pleasure sharing all the ups and […]
