Regulatory Focus: Week in Review (2-6 April)
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Posted: 6 April 2012
By Alexander Gaffney
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Regulatory Focus is proud to bring you 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.
Missed last week's Week in Review? You can find it here.
Top News Items
Proposal Would Overhaul FDA Accelerated Approval Pathway
A new piece of legislation released in discussion draft form by the Senate Health, Education, Labor and Pensions Committee aims to "overhaul" the US Food and Drug Administration (FDA) Accelerated Approval pathway, reports The Hill. More »
EMA's Abadie Resigns as Chair of CHMP
The European Medicines Agency (EMA) announced 4 April that effective immediately, Eric Abadie, chair of the Committee for Medicinal Products for Human Use (CHMP), was resigning from his position. More »
New FDA Program to Boost Regulatory Science, Speed Drug Development
The US Food and Drug Administration (FDA) announced the launch of a new program intended to advance clinical trial design and endpoints to boost regulatory science and facilitate expedited drug development. More »
Global Global API Inspection Scheme Ramps Up, Seeks New Members
The participants in an active pharmaceutical ingredient (API) inspection program involving many of the world's premiere global regulatory bodies recently announced the intent to standardize the inspection schemes of its member nations and advance "administrative simplification." More »
United States News
Guidance and Draft Guidance for Industry
FDA Information
- Shuren’s Senate Testimony Yields Wealth of Insight (Regulatory Focus)
- Woodcock Testifies on PDUFA, FDA Drug Approval Performance (Regulatory Focus)
- Proposed FDA Rules for UDIs, Laser Products Continue to Languish at OMB (Regulatory Focus)
- New FDA Standard on Cargo Theft Released (Regulatory Focus)
- Report: Clashes Between White House, FDA Frequent (Regulatory Focus)
- FDA-Backed Collaborative Research Fund Off to Slow, Controversial Start (Regulatory Focus)
- FDA, ISMP Announce New Initiative to Reduce Medication Errors (Regulatory Focus)
- Global API Inspection Scheme Continues to Ramp Up, Calls for Additional Members (Regulatory Focus)
- IOM: Boost Foreign Regulatory Capacity to Ensure Drug Safety (Regulatory Focus)
- FDA Creates Program to Boost Regulatory Science, Speed Drug Development (Regulatory Focus)
- Joint FDA, Chinese Training Helping to Boost Product Safety (Regulatory Focus)
- FDA Close to Approving J&J Drug Via Animal Rule Pathway (Regulatory Focus)
- Industry Groups Have Concerns With Off-Label Drug, Device Info Draft Guidance (Bloomberg)
- FDA MAPP - 4652.1 Property Management Program (FDA)
- FDA Medication Guides Updated 30 March (FDA)
- Panel Skeptical on Home Anthrax Rx Kits (MedPage Today)
- MedSun: Newsletter #71, April 2012 (FDA)
- FDA Statement about Product Quality of Parenteral Vancomycin Products (FDA)
- FDA’s Third Annual Report to Congress on 505(q) Citizen Petitions; Agency Says the Jury is Still Out on the Petition Law, But There are Concerns (FDA Law Blog)
Other US News
Congressional Actions and Political News
The Courts
Workshops & Meetings
Agency Information Collection Activities; Proposals, Submissions, and Approvals
Warning Letters & Prominent Recalls
European News
News and Other EMA Information
Work Instructions, SOPs, and Regulatory and Procedural Guidelines
Meetings and Workshops
Global Regulatory News
Other News and Interesting Reads
Important Studies, Whitepapers and Research