Regulatory Focus™ > News Articles > Regulatory Focus: Week in Review (16-20 April)

Regulatory Focus: Week in Review (16-20 April)

Posted 20 April 2012 | By Alexander Gaffney, RAC 

Regulatory Focus is proud to bring you another edition of Week in Review-a recap of the global regulatory news space for the preceding week. If you read just one thing this week, make it Regulatory Focus' Week in Review.

Previous Week in Reviews: [9-13 April] [2-6 April] [26-30 March]

Top News Items

Drafts of PDUFA, MDUFA Released in House, Senate
Congressional committees responsible for the oversight of the US Food and Drug Administration (FDA) released discussion drafts intended to start the debate over the reauthorization of the Prescription Drug User Fee Act (PDUFA) and Medical Device User Fee Act (MDUFA).  More »

New Pilot Seeks to Dramatically Speed up 510(k) Reviews
A new pilot program announced by the US Food and Drug Administration's (FDA) Center for Devices and Radiological Health aims to dramatically speed up 510(k) medical device reviews for manufacturers of certain in vitro diagnostic and radiology products. More »

Indian Drug Regulator's Office in Limbo
The Economic Times of India reports the Drug Controller General of India (DCGI), the regulatory body in charge of approving drugs and clinical trials, exists in a state of "limbo" after a series of power struggles and vacancies. More »

SCOTUS Rules Company Can Sue Novo Nordisk For Delaying Generic
The Supreme Court of the United States ruled 17 April that Caraco Pharmaceuticals can proceed with a lawsuit against Novo Nordisk over Nordisk's purported attempts to prevent Caraco's generic entry into the market. More »

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