Tomorrow, the FDA will issue a final rule (see prepublication document here) very similar to its proposed rule published in the Federal Register on September 12, 2018. The notice states “[I]n this final rule, FDA repeals the irradiation regulation, which provided that any drug sterilized by irradiation was a new drug. OTC drugs marketed pursuant to […]
Based on our post previewing the November totals, there were some late added approvals that did not initially show up on the Agency approval databases. We reported 49 full approval actions and 8 tentative approval actions on December 3rd. With the release of the official November numbers (here), OGD issued 59 full approval actions and […]
In a blog post, Kurt Karst (Hyman, Phelps, and McNamara) addressed at least one very significant issue the proposed Blocking Act of 2019 could have (here). Many believe that the change from the current legislative language may erode the value of 180-day exclusivity and, in the long run, could lead to higher drug prices. The […]
The International Society of Pharmaceutical Engineering (ISPE) held their premier Global Pharmaceutical Regulatory Summit conference this past Thursday and Friday (December 5 – 6, 2019) in Bethesda, MD. The theme of this year’s conference was “Igniting Innovation in Development & Quality During Lifecycle Management”. The conference opened with excellent keynote presentation from Janet Woodcock (Director […]
N-Nitrosodimethylamine (NDMA), which was previously found in angiotensin II receptor blockers (the ‘sartans”), which are blood pressure medications, and more recently, in ranitidine (a heartburn medication) has caused nationwide recalls of the products. Now there is a hint that metformin, a widely used drug for diabetes, may be implicated as well, as Singapore’s Health Sciences […]
Just look around, watch the television, read the newspaper, and what do you see? Seems like very few reasons to be thankful. School and workplace shootings, the political scene is as nasty as I ever remember in my 70 years on earth. Climate change is threatening the future of our children, and the environmental controls […]
I have recently touched upon the subject of nitrosamines in drug products as part of a blog on Extraneous Peaks (here). The concern about nitrosamines in drug products continues to grow, and it will be a significant challenge for the regulators and pharmaceutical industry to establish meaningful policies and procedures to ensure there are no […]
[vc_row][vc_column css=”.vc_custom_1570720331401{margin-bottom: 20px !important;}”][vc_column_text]Aloka Srinivasan, Vice President, Regulatory Practice at Lachman Consultants recently wrote an article for PharmTech, detailing the Proactive Evaluation of Possible Genotoxic Impurities During the Early Stages of Drug Development. The article provides a direction for identifying genotoxic impurities early in the drug development process, regulating genotoxic impurities at acceptable levels in […]
In his article “Endo comes out on top in its fight with FDA and bulk compounder” published in Fierce Pharma (here), Eric Palmer has pointed to a potentially precedent-setting decision that may have further implications for the outsourcing compounding community. The FDA has a long-standing policy regarding the marketing of unapproved drugs after the first […]
In three separate Federal Register Notices, the FDA announced the fee for the use of certain priority‑review vouchers (here, here, and here). Priority-review vouchers are awarded to a firm that that gains approval for a designated tropical disease, a material threat medical countermeasure, or a designated rare pediatric disease when an application is approved for […]
