The User Fee negotiations are still underway and those discussions must be finalized soon or you may not have many folks to speak to at FDA. Yes, there is some carryover money but no one knows for sure how employees will react if pink slips go out. It now looks like September 15th will be […]
In today’s prepublication of the Federal Register appears the final rule entitled Annual Summary Reporting Requirements Under the Right to Try Act (here). The Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina, Right to Try Act of 2017 (Right to Try Act), was signed into law on May 30, 2018. This Act provides an […]
A 300% increase in anything gets attention, however, when it is a “rule governing medicinal product in the European Union” it demands attention and action (EudraLex – Volume 4 (europa.eu)). Annex 1 which is the guide for the “Manufacture of Sterile Medicinal Products” (20220825_gmp-an1_en_0.pdf (europa.eu)) was just released on 22 August 2022. This document is […]
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The FDA released a draft guidance titled Statement of Identity and Strength — Content and Format of Labeling for Human Nonprescription Drug Products: Guidance for Industry (here) which, not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 […]
