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Key Regulatory Topics: The eCTD 2014 RAPS: The Regulatory Convergence RAPS Learning Solutions RAPS Store - The source for regulatory knowledge RAPS Executive Development
Key Regulatory Topics: The eCTD
2014 RAPS: The Regulatory Convergence
RAPS Learning Solutions
RAPS Store - The source for regulatory knowledge
RAPS Executive Development

RAPS & Regulatory

RAPS is the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products. Founded in 1976, RAPS helped establish the regulatory profession and continues to actively support the professional and lead the profession as a neutral, non-lobbying nonprofit organization. Read more »

 Upcoming Events
Event: Chapter

Chapter Event
Key Enforcement, Legal, Regulatory and Policy Updates
24 April 2014 | Bridgewater, NJ

Event: Chapter

Chapter Event
Spring Networking Reception
24 April 2014 | Sandy Springs, GA

Event: Advertising, Promotion and Labeling: the US Regulated Environment

Virtual Program
Advertising, Promotion and Labeling: the US Regulated Environment
30 April 2014 | Online

Event: RAPS Executive Development

Workshop
RAPS Executive Development
2–5 June 2014 | Evanston, IL

Event: 2014 RAPS: The Regulatory Convergence

Conference
2014 RAPS: The Regulatory Convergence
27 September–1 October 2014 | Austin, TX


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 Community
Join the discussion -- RAPS Regulatory Exchange

RE:Timing of Self-identification and GDUFA Fees
Posted: 4/23/2014 5:25:29 PM
From : Discussion Post>>Regulatory Open Forum
Charles, Not sure I understood your question. Is the new generic drug you are preparing to manufacture an FDA approved drug for commercial distribution? If you answer is yes, then you will need to identify as a generic manufacturer ...

RE:Shelf life extension of DES during clinical trials
Posted: 4/23/2014 1:57:01 PM
From : Discussion Post>>Regulatory Open Forum
------------------------------------------- John O'Neill John ONeill Enterprises LLC San Mateo CA 94404 United States ------------------------------------------- Hani, If you have the original stability studies used to just...

RE:Shelf life extension of DES during clinical trials
Posted: 4/23/2014 12:48:51 PM
From : Discussion Post>>Regulatory Open Forum
Hani, Are you asking what mechanism (notification) to FDA is needed or are you asking a different question? Did you agree on a stability protocol with FDA that goes beyond 6 months? Dar ------------------------------------------...

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