The GDUFA II reauthorization process involved a lot of agreements from the FDA. One of those agreements was for the Agency to publish a guidance on changes to drug substances that addressed the type of changes, their categories for submission (PAS, CBE, CBE-30, or annual report) and the necessary documentation that must be submitted to support the proposed changes.
The Association of Accessible Medicines (AAM) meeting in Baltimore this week saw a number of FDA presentations. One that caught my attention was presented by Sarah Barkow, Ph.D., Acting Director, Manufacturing Quality Guidance and Policy Staff, Office of Manufacturing Quality in CDER. It had to do with data integrity.
Dr. Barkow noted, “about 40% of OMQ’s warning letters include data integrity lapses.
According to our best calculations and current data on the FDA “All Approvals” page (here), it appears OGD has approved forty-seven ANDAs and tentatively approved eleven ANDAs in the month of August. These numbers are far below the record breaking ninety-six full and thirty tentative approvals seen in the month of July.
As we know July was a record breaking month for approvals as reported here, but it was also a record shattering month for Complete Response Letters, beating the October 2017 previous total of 325 with a whopping 357 CRLs. This may be a little disturbing as the trend in FY 2018 is for an overall increase in CRLs.
The FDA announced today (here) the first approval of a generic equivalent to Epi-Pen, the combination product used to treat severe allergic reactions. The FDA’s announcement acknowledges that approval of “complex” generics, like some combination (drug/device) products, can be very challenging.
The FDA has always said that for most complex drug device products,
Well, after a couple of comments on my post (here) regarding timelines for resubmissions of MDAs, BLAs, and efficacy supplements, it came to my attention that this was an older MaPP.
Sorry for the confusion but it came up as new on a daily feed I routinely review for blog material.
Many articles had decried the fact that biosimilar uptake is not what FDA or the drug industry anticipated. Look, I have been around in this industry in one form or another (pharmacist, regulator, and consultant) for 46 years and have seen a lot in my day. They say history repeats itself – no I am not planning to go back to FDA – but the same concepts and forces are in play today as they were when Hatch-Waxman (H-W) was first passed.
First-time generic approvals are always good for the public and the industry. Through June, there were only 34 first approvals for the calendar year (an average of about 5.6 a month) and it looked like 2018 was going to be a slow year. Then came the July first‑time approval postings (here),
While we reported that July had already broken the previous approval record prior to the official July numbers being posted in an earlier post (here) we were happily shocked when the official approval numbers came out today (here). OGD fully approved a record 96 ANDAs (previous record was 88 in June FY 2017) and tentatively approved 30 ANDAs (previous record was 23 in November 2017 (also in FY 2018) for a total 126 approval actions!
After a disastrous start to the new year and the significant slowdown in approvals resulting from the OGD’s strict application of the provisions of the USP Elemental Impurity Chapter while awaiting harmonization with ICH Q3D, the approvals have begun flowing again. There are some changes in the final guidance (here) from the draft that the FDA made in the harmonization effort.
The National Drug Code (NDC) number is a unique identifier for prescription drug products. The format, as explained by the FDA below, will need to be changed in the coming years to accommodate the entry of new labelers into the U.S. market. The advanced Federal Register Notice published today (here) outlines the issues and announces a public hearing on the topic.
Sometime today, according to a pre-publication in the Federal Register, the FDA will post twenty-six new bioequivalence guidance documents and announce the revision of seventeen more. Since February 2018, the FDA has issued sixty-one new guidances and revised forty.
The OGD has indeed been busy but while the industry loves to see the new guidances,
In my 44 years in the industry, I don’t think any issue has raised as many questions, caused companies to scratch their heads or raised the level of angst more than the issue of the dreaded Field Alert Report (FAR). Well now – and finally – the FDA has issued a Q&A document that answers many of those head- scratching questions.
When an NDA holder lists a patent in the Orange Book (OB), it sometimes appears that the patent listing use claim, or other information is challenged by prospective ANDA applicants. FDA has updated its Listing of Patent Disputes (here) through July 13, 2018. This is the first time that we have seen this list (maybe we were asleep at the switch),
FDA approves two types of drug products –Prescription (Rx), and Over-The-Counter (OTC). Well, they also approve other types, i.e., Biologics etc., but for the purposes of this Blog post, it is the Rx and OTC that are applicable.
Prescription drugs require the intervention of a health care provider, and are typically for products where the patient cannot self-diagnose the condition for which the product is intended.