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 […]
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; […]
While FDA has allowed charging for investigational drugs since the 1987 “Charging Rule” went into effect, the Agency has been responding to questions from industry ever since. In 2009, the FDA revised the Charging Rule itself. The revised guidance (here) discusses these changes and notes that the “FDA’s regulations on charging for investigational drugs under […]
Today, the FDA released an alert (here) warning of potential cross-compatibility issues with the use of autoinjectors for injection of the glatiramer used for the relapsing‑remitting form of multiple sclerosis. The alert is directed at patients, caregivers, and healthcare providers. The FDA says it has “has received reports that using an autoinjector that is not […]
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 […]
Today, the FDA advised that it “recently became aware of a nitrosamine impurity, Nitroso‑STG‑19 (known as NTTP), in certain samples of sitagliptin, a medicine used to treat type 2 diabetes mellitus. To avoid a shortage and help ensure patients have access to an adequate supply of the medicine, the FDA will not object to the temporary […]
With a flurry of approvals at the end of the month, the unofficial count of approval actions for July 2022 breaks out as follows: 65 full approval actions and 12 tentative approval actions, for a total of 77 approval actions. This is the 7th out of 10 months that the total approval actions have broken […]
With just three months left in FY 2022, the OGD provided its update, adding the rest of the June statistics. We now have a full picture of the first three quarters of the metrics provided in the FDA Generic Drugs Program Activities Report – Monthly Performance. Here are some highlights of the complete June report […]
