Tag Archive: FDAMA

Oct 12 2012

Meningitis Tragedy Leads to Calls for Increased FDA Oversight

On 25 September 2012, three lots of steroid injections intended to treat pain were recalled by the pharmaceutical compounding company New England Compounding Center (NECC) in Framingham, MA, because of fungal contamination.  By Thursday, 11 October 2012, 12 people had died and there were 137 confirmed cases of fungal meningitis due to contaminated injections.  The …

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Sep 07 2012

De novo device reclassification: What have you done for me lately?

The recently passed FDA Safety and Innovation Act makes major changes to the de novo reclassification process for medical devices.  Namely, the new law mandates that a manufacturer can simply submit a request to the FDA for de novo classification without having a previously rejected 510(k) application. Medical devices are classified in a three-tiered classification …

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Jun 12 2012

PET Drugs – Time to file that NDA, ANDA or IND

No more Nice Guy.  FDA is stopping Enforcement Discretion for facilities producing positron emission tomography (PET) drugs for clinical use effective Tuesday, 12 June 2012. The long and tortured history of PET Drug products regulation began in 1997, when Congress passed the Food and Drug Administration Modernization Act (FDAMA).  One of the sections in this …

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