We are pleased to announce that Lisa Tinsley has accepted the position of Director in the Compliance Practice at Lachman Consultants, effective December 1, 2017. Ms. Tinsley is a 25-year pharmaceutical compliance and remediation professional who has led global compliance and auditing teams, developed Quality leadership and strategies, and enhanced Quality Systems. She is well […]
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 […]
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 […]
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 […]
Well, here we are, just before Thanksgiving again. It seems like just last week we were getting ready for last year’s shindig. We certainly have a lot to be thankful for this year and on top of the list is a clean bill of health after a horrible 2016 for my family. Second is the […]
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 […]
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 […]
The first Activities Report of the Generic Drug Program FY 2018 (here) issued today and it is a record breaker for approvals and Complete Response Letters (CRL). FDA broke the 100 mark with 101 approval actions with 87 full approvals (AP) and 14 tentative approvals (TA) (we predicted about 84 APs and 13 TAs back […]
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, […]
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 […]
