Regulatory Affairs

06
Oct

The MaPP to Nowhere!

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 […]

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23
Sep

Stuck on you – Now in Technicolor

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!

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18
Sep

This Road Has Been Traveled Before? Chance of Success Approaching Zero!

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.

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17
Sep

Reporting of Serious Adverse Events for Dietary Supplements and OTC Drugs – A Simple Idea

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.

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