Terrified businessman with crystal ball

Two-Thirds of the Way through January, Approval Action Totals Signal A Below-Average Month

With seven of twenty-two business days left in the month, the OGD stands at twenty-seven full‑approval actions and seven tentative‑approval actions.  The FY 2020 average for each category so far is just under fifty‑eight full‑approval actions and twelve tentative‑approval actions.  Unless the end of the month picks up, we could see the slowest month for approval actions this FY.

Completed

“Complete” Means “Complete”

“Complete” seems like a simple unambiguous word.  So why do so many firms struggle with complying with the following two predicate rules of cGMP compliance?

  • 21 CFR 211.188 Batch production and control records (here)

“Batch production and control records shall be prepared for each batch of drug product produced and shall include complete information relating to the production and control of each batch.”

  • 21 CFR 211.194(a) Laboratory records (here)

“Laboratory records shall include complete data derived from all tests necessary to assure compliance with established specifications and standards,

December 2019 Approvals and Receipts – Big Month for New ANDAs

With the end of the first quarter of FY 2020 approaching, the official numbers from FDA show a big jump from the meager number of new ANDA submissions the first two months of this FY with the December receipts hitting a 2 year high at 149.  Of course, this is likely due to getting the submission in to meet end of the year goals for industry,

OGD Approves 108 First Time Approvals in CY 2019

OGD reported the approval of 108 first time generic approvals in CY 2019.  This is the highest total in at least 4 years, with previous totals of 99 for 2018, 80 for 2017, and 73 for 2016.  There are many reasons for variations in the number of first approvals, some of which relate to the number of products that may be eligible for approval after a period of New Chemical Entity exclusivity,

FDA Publishes List of 249 ANDAs it Proposes to Withdraw

In the Federal Register pre-publication notices today, the FDA announced an opportunity for hearing for 249 ANDAs that it proposes to withdraw because the applicants have repeatedly failed to submit Annual Reports.  The notice announces the opportunity for a hearing for any of the applicants.  Many of the ANDAs are old applications, with some from companies that have been out of business for years;

OGD Updates November 2019 Metrics

Today is January 8th and the OGD just updated the November 2019 metrics (here) with the following information of interest: the OGD refused-to-receive three ANDAs (all of which were standard applications) and acknowledged fifty-five original ANDAs.

There were twenty ANDAs withdrawn in November (two were approved ANDAs that were likely no longer marketed) and eighteen were unapproved applications. 

The Role of Risk Assessment within Data Integrity

The World Health Organization (WHO) issued a draft guidance document titled “Guideline on Data Integrity” (October 2019) and within the document there is the statement:

Quality risk management (QRM), control strategies and sound scientific principles are required to mitigate such (Data Integrity) risks

and then further it states:

“application of QRM with identification of all areas of risk to DI through data integrity risk assessment (DIRA) and implementation of appropriate controls to eliminate or reduce risks to an acceptable level throughout the life cycle of the data”;

Rest in Peace

If You Knew Don Hare, You Loved Him

I am saddened to report that on Saturday January 4, 2020 my (our) good friend Don Hare passed away peacefully after a brief illness.  When I heard the news, my heart broke.  For those of us in the FDA or in the drug industry, he stood as a man among men and will be sorely missed by all that knew him. 

Recall of Mirtazapine and FDA Warning Regarding Gabapentinoids Headline Agency Announcements Today

The Agency issued two warnings today, one about a recall due to a drug-strength labeling error for Mirtazapine and the other regarding a potential serious adverse event, breathing difficulties, associated with the use of gabapentinoids.

It appears that there was a label mix-up with a single lot of Mirtazapine and “Aurobindo Pharma USA,

Pre-Launch Activities Importation Request (PLAIR) Q&A Document Published by FDA

The Q&A document addresses a number of frequently asked questions about the Pre-Launch Activities Importation Request (PLAIR) process, and when you can or cannot use a PLAIR for importing unapproved drug product into the United States.  Quite interestingly, there are quite a few answers of “no” to the FAQs, which likely demonstrates that firms have been trying to apply the PLAIR process to situations for which it was not intended.

Our Holiday Gift (or Torture) to Our Readers

Each year at holiday time, we try to provide a little levity in some of our blog posts, as well as spread some good cheer.  So here you go – love it or not – we fully expect this to be sung outside Building 31 in Bethesda on the evening of December 24th.

To the tune of “Winter Wonderland,” this is “Winter Wonderland,

Proposed Rule for Drug Importation from Canada Hits the Federal Register

Today’s prepublication of the Federal Register contains the proposed rule for drug importation from Canada.  The proposed rule is 172 pages long and outlines the FDA expectations for the safe importation of drug products from Canada.  Section 804 Importation Programs (SIPs) provides the basis for each request for importation and provides the importation requirements.  The supply chain for each drug under a SIP would be limited to three entities,