FDA Provides Interesting Enforcement Information

FDA posted Donald Ashley’s, Director of the Office of Compliance (OC), presentation (here)   at the FDLI Enforcement, Litigation, and Compliance Conference presented December 6, 2017.  Mr. Ashley provided some interesting enforcement information, some of which is presented here.

The FDA’s Biomedical Monitoring (BIMO) program warning letters issued over the last 4 fiscal years is captured in the slide below.

November Another Big Month for OGD Approval Actions

Based on the FDA’s All Approvals list (here), by my count, it appears that November was another good month for FDA approval actions.  Looks like OGD will report at least (we know that until OGD publishes its official numbers, this is just an estimate) 84 full approvals and 15 tentative approvals for a total of 99 (just 2 less than last month’s all-time high monthly total of 101 during all GDUFA).

First Once-a-Month Buprenorphine Injection Approved

For the battle to fight opioid addiction and the so-called opioid use disorder (OUD), the FDA has given patients and practitioners another tool.  This once-a-month injection is indicated for OUD for patients on a stable dose of buprenorphine for at least 7 days.  Previous treatments with this drug required daily doses of orally administered products like films or tablets,

First Once-a-Month Buprenorphine Injection Approved

For the battle to fight opioid addiction and the so-called opioid use disorder (OUD), the FDA has given patients and practitioners another tool.  This once-a-month injection is indicated for OUD for patients on a stable dose of buprenorphine for at least 7 days.  Previous treatments with this drug required daily doses of orally administered products like films or tablets,

21 Page Response Again Confirms FDA’s Previous Position on ODE and H-W Exclusivity Carve-outs

Without going into a lot of detail, suffice it to say that the FDA has again rebuffed attempts to delay a 505(j) or 505(b)(2) version of a drug product protected by various periods of Orphan Drug Exclusivity  (ODE) and/or Hatch-Waxman (H-W) exclusivity, in a November 6, 2017 denial of a Citizen Petition from the innovator (here) .

Final Guidance on Abuse-Deterrent Opioid Generic Drug Testing Arrives – High Burden of Proof!

FDA published its final guidance on General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products (here) as perhaps a Thanksgiving present to the generic drug industry.  The theme throughout the document is “[i]f the summary in section 9.2 [of the RLD labeling] indicates that FDA has concluded that the product has properties that are expected to (or have been shown through postmarketing studies or trials to) deter abuse,

Stand Up and Take Notice

Well, in the dietary supplement battle for the erectile dysfunction (ED) market, it seems that FDA continues to find supplements that contain undeclared drugs.  In a public notification today, FDA advised consumers not to use yet another product for ED (see here).  As reported previously, it seems that FDA issues a few notices a month for products claimed to be dietary supplements,

AAM Session on Bioequivalence Provides Food for Thought and Good Recommendations

The Path to Bioequivalence – Great Progress – Great Opportunities, was presented by Charlie DiLiberti, President, Montclair Bioequivalence Services LLC, at this week’s Association for Accessible Medicines (AAM) meeting.  Charlie pointed out the great progress FDA has made in developing new bioequivalence techniques or alternate methods through the GDUFA regulatory science initiative.  He pointed to the many new BE guidance recommendations,

Tidbits from the AAM Fall Tech Meeting – Day 1 to Day 1.5

Lots of topics have been discussed on the first two days of the Association for Accessible Medicines (AAM) Fall Technical Conference.  Many of the detailed presentation and speakers’ comments had what I refer to as hidden gems that might have escaped full view.  Here are some of the noteworthy tidbits:

  • What about those ANDAs that have had complete responses?

Cook Gives State of OGD Report at AAM

If you have been reading my blog regularly, I guess I have gotten much of the reading of the wind correct because there was not a lot of new information in Cook’s (Kathleen Uhl M.D., Director, Office of Generic Drugs) talk at this year’s Association of Accessible Medicines (AAM) Fall Technical Conference in Bethesda, MD. 

FDA’s Center for Tobacco Products Seeks $279 Fine in Complaint

Now, I usually don’t try to second guess the FDA, and I certainly do not know much about the Center for Tobacco Products.  In addition, I do not condone underage smoking, nor do I condone smoking at all and consider it one of the most significant threats to public health.

The complaint (here) seeks a fine of $279 for two violations of selling tobacco to a minor under the age of 18.