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 […]
For those of you who have not yet read MaPP 5200.3 (here). Responding to Industry Inquiries with Respect to Abbreviated New Drug Application in the Office of Generic Drugs, you better have your CEOs take a Valium prior to your reporting its contents. In a nutshell, it says you can call us – but only the […]
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.
IntelGenx Corporation of Saint Laurent, Quebec, Canada submitted petition FDA-2013-P-1058 (here) on August 22, 2013, asking the FDA to designate its Rizatriptan Oral Film product as AB rated (or therapeutically equivalent [TE]) when approved to Maxalt-MLT Orally Disintegrating Tablets, the reference listed drug (RLD) cited in its 505(b)(2) application. The fact that the two products might perform similarly does not overcome the fact that the products are different dosage forms.
Since December 22, 2007, the Dietary Supplement and Nonprescription Drug Consumer Protection Act has required that serious adverse event information be reported to FDA for dietary supplements and OTC drugs not approved through a new drug application. There are many questions that can come up as soon as you dig a little deeper into what is required. Some answers will be provided here, but these are meant only to call attention to the potential complexity and depth of these requirements.
Today, the FDA released Revision 1 to the Draft Guidance to Industry: Generic Drug User Fee Amendment of 2012: Questions and Answers. This 36 page document contains additional questions and answers (as well as clarifications) to some of the issues raised in the original draft guidance issued on August 22, 2012.
The FDA has announced on the Federal Register (FR) prepublication page the availability (tomorrow) and publication of two documents that will be of significant interest to the industry.
Today the FDA issued the long awaited Guidance to Industry: ANDAs Stability of Drug Substances and Drug Products in draft answering questions the public submitted relative to the final ANDA stability guidance document issued September 25, 2012.
