To follow up on last week’s blog (here). I came across the Amicus Curiae brief filed by the Solicitor General in the Teva v Glaxo case regarding the skinny label provisions of the Hatch-Waxman Act. I thought you would be interested in reading the brief for this important case so here it is! Enjoy the […]
That’s right! Get ready, get set, GO! Beginning March 27, 2023, OGD will start to accept requests for Face to Face (FTF) meetings again. However, according to the FDA announcement, FTF meetings will be limited to “pre-ANDA product development meetings and pre-submission meetings for which the applicant requests this in-person FTF meeting format.” Access may […]
An email from the FDA explained that on March 17, 2023 the FDA added information to the Purple Book Database of Licensed Biological Products (here) to include information on new reporting requirements established by the Section 3201 of the Consolidated Appropriations Act of 2023. According to the Purple Book Q&A #8: “Section 506I(c) of the […]
Let me start off by saying Holy Cow! This month looks like it could be a blockbuster for approval actions, but there are some interesting factoids that must be taken into account. Let’s look at the reported approval actions posted through March 15th and I will further explain some of the twists. It looks like […]
Today, the FDA issued a draft guidance titled Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act (here). The various terms fall under the general areas identified in the DSCSA as Suspect Product and Illegitimate Product, and this guidance will help clarify how to further identify and […]
With the prevalence of COVID-19 still relatively high, with flu season upon us, and with symptoms of both infectious diseases being pretty much the same, how many of you have wondered when sick, Do I have COVID or the flu? You could always test for COVID but never had the option to home test for […]
Today, the FDA issued a total of thirty Product Specific Guidances (PSGs) – twenty‑one new and nine revised (here). The FDA notes that all twenty‑one newly issued PSGs are for drug products for which there are no approved ANDAs. In addition, of the thirty guidances issued, nineteen are for complex products (fourteen new and five […]
CMS realizes that some drugs approved through the FDA’s accelerated-approval process won’t prove to be safe and effective in final analysis. It wants to balance its payment for products that might not pan out in confirmatory trials by trying to make firms sprint, rather than crawl, to finalizing such studies. How? Well, we know that […]
An AAM blog posted this morning (here), titled The Quickest Route to U.S. Essential Medicines Production: Existing and Idle Production Sites, seems to think that the answer to this post’s titular question is Yes, and it at least provides another option for consideration. The AAM post cites a report (here) by Professor Anthony Sardella from […]
On February 9, 2023, the FDA issued a revised guidance (here) on the compounding of Ibuprofen oral suspension products for outsourcing facilities. We previously posted about the original document (here) and discussed the basic factors that caused the Agency to issue the guidance without public comment to meet the needs of a drug shortage that […]
