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,

Should an HBEL (Health Based Exposure Limit) be the Basis for Acceptance Values for Manufacturing Cleaning Validation?

The answer to the question of whether current cleaning validation limits generally in use in the industry (1/1000th of the minimum therapeutic dose of a drug product or 10 ppm) should be revised in favor of a Health Based Exposure Limit (HBEL) based limit was one of the major discussions at a “Workshop on the Generation and use of Health-Based Exposure Limits” held on 20-21st June 2017 at the European Medicines Agency.

Jose L. Toro, Ph.D., new Principal Consultant at Lachman Consultant Services, Inc.

We are pleased to announce that Jose L. Toro has accepted the position of Principal Consultant in the Compliance Practice at Lachman Consultants, effective November 13, 2017.

Dr. Toro has extensive R&D Quality, and Quality Operations experience in the pharmaceutical industry.
He specializes in the transformation of Quality and Technical Services organizations including Quality Systems,

Don’t Disregard Your OOS Rate

As stated in the FDA November 2016 draft Guidance, Submission of Quality Metrics Data – Guidance for Industry (here), one of the Quality Metrics that the FDA intends to monitor is the Invalidated Out-of-Specification (OOS) Rate (IOOSR).  The IOOSR quality metric is the number of OOS test results for lot release and long-term stability invalidated by the covered establishment due to an aberration of the measurement process divided by the total number of lot release and long-term stability OOS test results. 

Compounding Pharmacies Still in FDA’s Crosshairs

From August 2016 to October 2017, FDA has issued 63 Warning Letters (an average of 4 per month) and has orchestrated 4 Injunctions and multiple prosecutions against Compounding Pharmacies and their Principals. Most of the Warning Letters deal with citations for insanitary conditions for compounding and for lack of sterility assurance for compounded preparations.

It is certain that FDA is continuing to apply pressure on this industry with no letup in sight.

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,

Learning the GDUFA II Language

Although the generic industry has come a long way in terms of Quality-by-Design or the desired space, it is still in early stages when it comes to Dates and Abbreviations as they relate to GDUFA.  It has been a little overwhelming to the participants of this year’s Association of Accessible Medicines (AAM) Fall Technical Conference in Bethesda,

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?

Do You Have a Story to Tell?

Giuseppe Randazzo, the Director of the Office of Program and Regulatory Operations, urged the generic industry to tell a story in a cover letter when sending a submission to FDA. Yes, that’s right.  At his presentation in Bethesda at the Association of Accessible Medicines 2017 Fall Technical Conference, Mr. Randazzo explained that a cover letter,

Improving Health of the Least of Us for the Benefit of All of Us – A Guest Blog

My previous guest blog post, “Taking Care of Our Neighbors” (here), was focused on improving the health of uninsured, low income Americans, and the Dispensary of Hope’s incredible collaborative network.  Today, my mind is on the need for a change in our economic perspective as it relates to improving the health of our uninsured friends,

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