With the demise of the Alzheimer’s drug aducanumab after the FDA’s accelerated approval and CMS’s actions to raise Medicare premiums in anticipation of huge demands based on its proposed pricing, we may now face another similar situation and that is with a drug for amyotrophic lateral sclerosis (ALS). After a 7-2 favorable vote by the […]
The FDA released a draft guidance titled Statement of Identity and Strength — Content and Format of Labeling for Human Nonprescription Drug Products: Guidance for Industry (here) which, not surprisingly, addresses the requirements for statements of identity and strength designations on the principal display panels (PDPs) of OTC drug products. The guidance notes that “[T]he […]
Join Lachman Vice President John McShane and Executive Director Keith Lamb with Arnold & Palmer attorneys Howard Sklamberg and Phillip DeFedele for a live webinar, FDA Manufacturing Compliance and Inspections for Cell and Gene Therapies and Other Innovative Biologics. The 1 hour session will be held on September 15 at 1:00 pm EST. Cell and […]
The nation has been struggling with drug abuse for as long as I can remember. The current opioid crisis keeps the problem on the front page, especially with fentanyl being disguised in a drug of abuse which has become one of the most deadly drugs of abuse in the long war on drugs. FDA has […]
In-person conferences continue to emerge as evidenced by the recent “GMP by the Sea” held on August 15, 16, 17th in Cambridge, MD. A well balanced conference, led by regulatory leaders, provided relevant “look backs” as well as prospective “look forwards” giving attendees a collective perspective of learning from the past as well as a […]
With just two months to go in FY 2022, the OGD has updated its July statistical report (here). With the hold‑up on the FY 2023-2027 User Fee legislation, some at the Agency are getting a bit nervous about their job security and firms are scrambling to try to budget for FY 2023 user fee costs; […]
Well, we just passed the midway mark for August 2022 and it looks like a potentially good month for ANDA approval actions. Thus far (at least posted through August 16th), the OGD has issued thirty full-approval actions and eleven tentative-approval actions, well on its way to a high-70s or low-to-mid-80s number of approval actions. We […]
With the long-awaited FDA final rule on OTC hearing aids entitled Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids is now on the books, the Agency has issued a final guidance (here) on these products which explains the differences between, and the new regulatory framework for both hearing aids and personal sound […]
While most of us were sleeping, the ICH has been busy revising nine of its guidances titled International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Effectiveness of Anthelmintics for different species. The prepublication of the Federal Register today (here, please scroll down to regular filings on the lefthand side of […]
July looks like another good month for OGD approval actions with a reported sixty‑five full‑approval actions and thirteen tentative‑approval actions. In a previous blog post, we reported sixty‑five and twelve in our unofficial counts (here). That darn additional TA was posted after our blog post (so close!). So, the OGD hit over the seventy‑mark again […]
