Regulatory Focus: Week in Review (23-27 July)
| Posted: 27 July 2012
By Alexander Gaffney
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 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 Week in Reviews: [16-20 July] [9-13 July] [18-22 June] [11-15 June] [4-8 June
Top News Items
Regulatory Moratorium Bill Passes House
The US House of Representatives passed a bill that would freeze many regulations, including those introduced by the US Food and Drug Administration (FDA), until unemployment falls to pre-recession levels.
FDA Releases Draft Guidance on 510(k) Submissions
The US Food and Drug Administration (FDA) has released a new draft guidance for its staff members and industry instructing them on how to assess the safety risks of small-bore connectors submitted through a 510(k) application.
FDA Fires Back at Legislative Critics, Blames Manufacturers for Drug Shortages
The US Food and Drug Administration (FDA) is seeking to distance itself from a June 2012 report by the House Oversight Committee claiming the regulatory agency is the root cause of drug shortages currently plaguing dozens of pharmaceutical products.
European Trade Regulators Charge Companies for 'Pay-for-Delay' Agreements
If industry practitioners of so-called pay-for-delay settlements are worried about the climate for the legal agreements in the US after a recent court ruling against the measures, they should be just as concerned about European regulators, reports Reuters and The Financial Times.
NICE to Assume Review of High-cost Orphan Drug Products
The UK’s national health technology assessment (HTA) body, the National Institutes for Health and Clinical Excellence (NICE), is set to start assessing what it refers to as the “very high cost of drugs for people who suffer with rare conditions” under the new Health and Social Care Act of 2012.
Regulatory Focus Features
[Editor’s Note: During the Month of July 2012, all Regulatory Focus Articles Are Accessible at No Charge]
Pharmaceutical and Biologics
Other US News
Compliance and Safety Issues
Workshops & Meetings
Deals, Acquisitions and Business
Regulation and Guidance
Other EU News
Global Regulatory News
Important Studies, Whitepapers and Research
Other News and Interesting Reads