The Government shutdown is on everyone’s minds, but, as always, things happen that many of us in the general public don’t think of right off the bat to keep the title’s metaphor going. The shutout comes for any fee-paying application, supplement, device or other FDA regulated product that industry attempted to submit to FDA on or after October 1, 2013.
This is not the first time that the Office of Generic Drugs (OGD) has issued a guidance document that requires firms to assure that they have essential information in their original abbreviated new drug applications to permit a substantive scientific review. Remember prior to the 1992 Hatch-Waxman final rule when an ANDA could be submitted […]
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!
