The breakthrough therapy designation (BTD), once awarded to a drug product under development, triggers a rather intensive use of Agency resources, such as providing “early and frequent advice, conduct multidisciplinary meetings involving senior managers, and when appropriate, expedite the review of resultant marketing applications.” The program is designed to “facilitate and expedite” review of promising […]
The FDA recently published an updated version of the Current List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic (here). The list is broken down into two parts that identify either prescription or over‑the‑counter drugs (that require an ANDA as the subject of approval), and each of these respective lists is broken down into two […]
The focus on beta‑lactam antibiotics has primarily concentrated on penicillin and its derivatives because of the issue of severe allergy or anaphylaxis that can occur in individuals with sensitivities to these products. Over the years, as more and more non‑beta‑lactam antibiotics were introduced to the market, there has also been growing concern that these new […]
There is no question that the Alzheimer’s drug Aduhelm has stirred up a lot of controversary. The action that CMS took related to reimbursement for the drug for Medicare patients and the initial yearly projected cost soured many stakeholders on the product, from prescribers to patients, as well as caregivers and healthcare providers, not to […]
The first day of the Food and Drug Law Institute’s Annual Conference started with an excellent keynote address from FDA Commissioner Dr. Robert Califf, who underscored the importance of the FDA engaging with industry to evaluate the promise (as well as risks) of new technology and medicinal products. Part of that dialogue happens at the individual […]
It appears that the tentative approvals for both May and June began appearing in force on the FDA’s All Approvals list and in the daily approval postings sometime this week. With that in mind, I want to update the unofficial approval action totals for May 2022, which we first reported here. The All Approvals report […]
The creation, tracking, and publication of quality metrics has long been a source of sensitivity and confusion. People may fear them because they feel that they don’t tell the whole story or that they may invite criticism and misinterpretation. Thus, quality metrics were held tightly close to the chest of business leaders. Deming identified this […]
The FDA issued a warning to consumers (here) that mole removal isn’t a DIY project and can be dangerous for a number of reasons. It warns that there is no FDA-approved OTC product for removing moles or skin tags. Unauthorized products, like those with a high‑level of salicylic acid, claiming to remove these lesions can […]
The FDA has updated its list of all ANDA final approvals for drug products that have received CGT designation. The list cites a total of 150 ANDAs and the first approval under the program dates back to August 8, 2018. So far in 2022, FDA has approved 29 such ANDAs, of which 10 have commenced […]
The FDA’s Pharmacy Compounding Advisory Committee will be considering the addition of four new ingredients for use for inclusion on the bulk list for 503A compounders to utilize in the compounding of prescription drug products. The four ingredients up for consideration are: Ammonium tetrathiomolybdate; Enclomiphene citrate; Ferric subsulfate; and Glutathione The Notice for the Advisory […]
