Janet Woodcock, M.D., Director, Center for Drug Evaluation and Research (CDER) noted that her vision of the reorganization for the Center is to have “one voice for quality across all drug products including biotech.” She also indicated that while this has been a need of CDER for a while, she gave GDUFA credit as a major driver of this current effort.
On October 24, 2013 the FDA announced its intent to recommend to the Drug Enforcement Administration (DEA) that Hydrocodone-containing combination products be rescheduled into the more restrictive Schedule II. Such a move will make it more difficult for patients to obtain the products, as well as for healthcare practitioners to prescribe these products.
Not that it is a big surprise to current users (at least we hope not), but the FDA announced on October 23, 2013 that they were completing the phase-out of all medical inhalation products containing chlorofluorocarbons (CFCs) by December 31, 2013.
In a recent enforcement action against a dietary supplement manufacturer James G. Cole Inc. (here), the FDA is seeking a Permanent Injunction based on repeated violations of cGMPs and distribution of unapproved drugs. This type of “health fraud” dates back to the days of the traveling medicine men in their covered wagons selling dangerous concoctions of different herbs and drugs and making all kinds of wild health claims for products like Doctor Feel Good Elixir.
On October 11, 2013, the FDA made history by approving Nasacort Allergy 24H, an over-the-counter (OTC) version of the Rx Nasacort AQ (triamcinolone acetonide), a nasally inhaled glucocorticoid for allergy relief.
Hardly! But Part 11 (21 CFR Part 11), which applies to records in electronic form and the use of electronic signatures required by predicate rule (i.e., those records required to be signed by GMP regulations), has been scrutinized and discussed among regulators and the industry over the years, and the industry is still waiting on […]
If you are a developer of apps for a mobile platform, are your apps medical devices, and if so, what requirements do you need to meet? The answer took FDA 43 pages to lay out in their new Guidance for Mobile Medical Applications, which was issued on September 25, 2013. And the answer is, well, it depends!
Today, the FDA announced a change in labeling requirements for all Fentanyl Transdermal Systems in an effort to prevent inadvertent overdose. FDA is also warning patients and caregivers to dispose of patches properly, and warning that patches that do not adhere properly to the patient might fall off and accidentally adhere to another person, such as a child or a caregiver, or even a pet, and, based on the amount of drug left in the patch (should this occur), could cause death!
GPhA filed a Citizens Petition on September 19, asking FDA to implement its INN naming policy equally to all biologics, and, in the Petition, articulated all the arguments as to why this is a necessity for future biosimilars being approved by FDA.
Oftentimes, over the years when I was working at the FDA, policy decisions were made way above my pay grade that did not really have buy-in from us program folks. In my further review of the FDA’s Draft Q&A Guidance on the implementation of the new stability requirements, I wondered if program and policy were […]
