Regulatory Focus: Week in Review (7-11 May)

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. We cover the news and regulatory intelligence from around the globe and bring it to you in one organized location. If you read just one thing this week, make it Regulatory Focus' Week in Review.

Previous Five Week in Reviews: [30 April - 4 May] [23-27 April] [16-20 April] [9-13 April] [2-6 April]

Top News Items

User Fee Bill Sails Through House Committee Vote (Regulatory Focus)
The House Energy and Commerce Committee today advanced the Food and Drug Administration Reform Act of 2012, a package of proposals to both fund and reform the agency, by a unanimous 46-0 vote.

Bill Introduced to Speed Development and Review of Breakthrough Therapies (Regulatory Focus)
A bipartisan bill introduced in the House of Representatives would speed up the development and review of some drugs intended to treat life-threatening diseases by creating a new "breakthrough therapy" designation at the US Food and Drug Administration (FDA). 

Scathing Parliamentary Report Blasts India's Drug Regulatory Authority (Regulatory Focus)
A parliamentary report authored by India's Standing Committee on Health and Family Welfare (SCHFW) is blasting the country's Central Drugs Standard Control Organisation (CDSCO), India's drug regulatory authority, calling it a "collusive nexus" between industry, government and medical experts, reports Reuters.

MHRA Launching New Anti-Counterfeiting Strategy (Regulatory Focus)
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) is unveiling a new Falsified Medical Products Strategy it says will improve its existing anti-counterfeiting strategy by enhancing communication, collaboration and regulatory activities between MHRA and stakeholders.

Regulatory Focus Features

ClinicalTrials.gov: Requirements and Implementation Strategies (Regulatory Focus)
The Food and Drug Administration Amendments Act of 2007 (FDAAA) established a requirement for certain clinical trials to be registered at trial initiation and to report summary results after trial completion in the public registry and results database called ClinicalTrials.gov. This law is intended to facilitate enrollment in clinical trials, allow for tracking of the progress of such trials and address problems with the lack of timely dissemination of research findings. This article discusses key considerations, helpful hints and some lessons learned to help meet the requirements of FDAAA as well as the trial registration policy of the International Committee of Medical Journal Editors (ICMJE).

Demystifying Electronic Data Standards for Clinical and Nonclinical Studies (Regulatory Focus)
As part of the Prescription Drug User Fee Act IV (PDUFA IV) information technology commitments, the US Food and Drug Administration (FDA) is moving toward a fully electronic, standards-based submission and review environment. FDA has issued a series of guidance documents to assist sponsors in providing regulatory submissions in electronic format.