November 2017

30
Nov

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 […]

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27
Nov

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 […]

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20
Nov
Petition to Request an Exemption from 100‑Percent Identity Testing of Dietary Ingredients Image

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 […]

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15
Nov

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 […]

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13
Nov

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, […]

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13
Nov
FDA Starts Push for Transparency in Fulfilling Their 2018 Compounding Policy Priorities Plan Image

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 […]

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10
Nov

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 […]

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