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 […]
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 […]
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 […]
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 […]
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 […]
I was lucky enough to moderate the panel on the Priority and Expedited Review with panel members Scott Tomsky and Kurt Karst at the Association for Accessible Medicines (AAM) on November 8, 2017. You all know them and it was interesting that the three of us were, without a doubt, on the same page. What […]
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 […]
