Well, we got the official November full ANDA approval numbers at 84 (previously reported here ), but we missed on the tentative approvals, which came in at a whopping 23 for a total of 107 approval actions. This is the second month in a row with greater than 80 approvals. In addition, for the second […]
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 […]
The new statistical report of the Activities of the Generic Drug Program (FY 2018) Monthly Performance (here) was posted on December 4, 2017. There are many new statistics being captured and to tell the truth I am not sure exactly what they all mean but I think I’ve got it straight. Please take a look at […]
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 […]
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 […]
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 […]
