Executive Briefing Series (formerly The Food & Drug Letter)

Jan. 13, 2012 | Full Issue in PDF Format

Abstract

Impending generic drug user fees, new rules for handling patent disputes and tighter controls in the global supply chain to prevent counterfeit medical products reaching the public. These are just a few of the challenges drug and devicemakers can expect to encounter as they head into 2012. Last year also saw updates on human subject protection rules and rougher scrutiny of investigator finances. For medical devices, there were few changes in regulation, but plenty of debate and planning for upcoming changes. These include the third iteration of the Medical Device User Fee Act authorizing the user fee program, the device tax and physician payment provisions of the 2010 Affordable Care Act and a hard look at the 510(k) premarket clearance process. Globally, companies face new regulatory frameworks in emerging markets, a recast of the EU device directives and new taxes by cash-strapped governments. Use the recap of key stories from 2011 in this issue of the Food & Drug Letter to reassess your programs and ensure future success in the U.S. and abroad.

GMPs: FDA Looked Beyond U.S., Transparency Tweaked in 2011

Efforts to secure the global drug supply chain were a key FDA concern in 2011, with the agency urging drugmakers to tighten supplier controls and aim high in their audits of foreign contractors.

Generic Drugs: User Fee Programs Top Industry’s Concerns in 2012

All eyes of the generic drug industry will be focused on Capitol Hill this year as Congress readies for action on the proposed Generic Drug User Fee Act (GDUFA) after years of FDA and industry efforts on the agreement.

Reducing Risk, Boosting Compliance in Clinical Trials

Concerned about the length of time it takes to get cancer trials from concept to initiation, the National Cancer Institute (NCI) set target time frames and drop-dead points for trials it funds.

Medical Devices: MDUFA, 510(k) Debate Made List of Top News

As the year ticked away, it became more clear that the FDA and devicemakers would not be able to compromise early enough to meet the Jan. 15 deadline for a report to Congress that was mandated by the current Medical Device User Fee & Modernization Act (MDUFMA).

Global Challenges Will Test Drug and Device Companies in 2012

Drugmakers should find it easier to get research grants for drug development due to measures adopted by the European Commission (EC) that revise the Seventh Framework Programme.

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