Elemental Elements Appear to Sink January Approvals

On January 11, 2018, we went out on a limb prognosticating that the very low numbers of ANDA approvals in January might be linked to a new USP requirement on documentation of elemental impurities that went into effect January 1st (see post here).  Since that time, the number of approvals has jumped from 2 to 4 (as posted on the FDA All Approvals site [here] through January 16th) but,

From Big Data To Cybersecurity, Today’s Device-Makers Face Myriad Compliance Risks – But Being Proactive Can Pay Off, Ex-FDA Official Says – article in Medtech Insight by Lachman Consultants

Too many medical device manufacturers are struggling because they don’t have policies and systems in place to handle the ever-growing amount of data they receive about their products once they’ve gone to market. As a result, important signals can go undetected or unaddressed, leading to compliance problems and devices that are of poor quality – both of which could ultimately affect a device-maker’s bottom line.

Never on Sunday!?

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 I flip through the FDA’s All Approvals list,

Anticipating trends in regulation – how do you get your information, and what do you do with it once you do?

In today’s global marketplace, industry is responsible for adhering to regulations in all markets that their products are in. Today’s pharmaceutical supply chain also likely contains partners that are across many geographic regions, and regulators expect conformity. In addition, regulators expect proactive compliance, and concerns about a retroactive “lack of assurance” of GMP are frequently the cause of a recall. 

First Quarter FY 2018 ANDA Approvals, Receipts and More!

Well, the first quarter of approval actions for original ANDA and receipts are in the books.  We reported late last week that OGD fully approved 78 ANDAs and tentatively approved 19 ANDAs – well, we were as close as we ever have been, estimating using numbers derived from various FDA statistical reports… and the official numbers for November 2018 are – 78 full ANDA approvals and 20 ANDA tentative approvals for a total of 98 approval actions. 

DUE FEBRUARY 14, 2018 – One-Time Report on Marketing Status Required by FDARA- Don’t Forget!

To reiterate our post of December 27, 2017 (here), please start working on your one time report on the marketing status of your products listed in the Orange Book.  The deadline is approaching and FDA even republished its advice to industry (here) again today!

Don’t be left without a retort – be sure to submit your report!  

Draft Guidance and a MaPP to Help Firms and Reviewers Get It Right the First Time (or Second Time)

Today, the FDA issued a draft guidance entitled “Good ANDA Submission Practices” (here) along with a new Manual of Policy and Procedure (MaPPs) 5241.3, entitled “Good ANDA Assessment Practices: Manual of Policies and Procedures.” These establish good ANDA assessment practices for the Office of Generic Drugs and the Office of Pharmaceutical Quality to increase their operational efficiency and effectiveness.

New Year – New Class Labeling for Combined Hormonal Contraceptives

It has been quite a while since FDA totally updated the class labeling guidance for combined hormonal contraceptives (CHC).  FDA notes “this newer CHC labeling may be different from the labeling for some older CHC products. The updates to this guidance set forth labeling recommendations that represent newer class labeling that should be included in all CHC prescribing information consistent with the labeling requirements set forth in the PLR and PLLR (21 CFR 201.56 and 201.57)…”  There have been some minor modifications such as the “Content and Format of Labeling for Human Prescription Drug and Biological Products;