Changes to Drug Substance Draft Guidance Come to Town!

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.  

DI Still a Major Problem – but What’s Being Done About it?

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.  

OGD Updates July 2018 Statistics

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. 

Complex Generics Get a Shot in the Arm (Leg Actually!) with First Generic Epinephrine Auto-injector Approval

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,

Biosimilars and Complex Generics Uptake Not as Expected – Why is that a Surprise?

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. 

OMG! OGD Shatters ANDA Approval Actions for July – and More!

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!

Avoid Another Elemental Impurity Meltdown – Read the Final Guidance

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. 

Ready Set Go! NDC Number Change Needed in Next Ten to Fifteen years

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.

26 New Bio Guidance and 17 Guidance Revisions since March 27, 2018

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,

FAR from Reality – Q&A Document Provides Answers to Age Old Questions

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.

FDA Updates Patent Listing Disputes

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),

More OTC Products Coming to a Shelf Near You?

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.