Regulatory Focus™ > News Articles > Regulatory Focus: Week in Review (15-19 October)

Regulatory Focus: Week in Review (15-19 October)

Posted 19 October 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. 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.

Week in Brief

The US Food and Drug Administration's (FDA) problems continue to mount as an outbreak of meningitis linked to vials of a steroid medication manufactured at a compounding pharmacy in Massachusetts continues to make ill hundreds of patients. Legislators tore into the agency this week, calling on it to release all records related to its investigations and oversight of the company-a possible preclude to a congressional hearing.

On the medical device front, FDA released three new guidance documents: two for review times under the Medical Device User Fee Act and a third pertaining to a soon-to-be-mandatory electronic submission program known as eCopy. On the pharmaceutical front, Bloomberg reported FDA is strongly considering a new paradigm for approving on a limited basis drugs with the potential to address public health needs such as obesity.

In the EU, European Commision (EC) Health Commissioner John Dalli was forced to resign due to a scandal in which he is alleged to have known about tobacco companies trading favors with government regulators. The UK's Medicines and Healthcare product Regulatory Agency (MHRA) meanwhile appointed a new head of its medical devices unit, while the European Medicines Agency (EMA) released a new guideline on acute heart failure therapies.

India, perhaps more than any other country, dominated the news cycle this week, with its regulators noting their intent to ban the introduction of branded generic medications in the country in the near future. In an unrelated move, Abbott Healthcare said it was suspending a marketing program in the country critics contended was an illegal effort to pay off doctors with items in return for prescriptions.

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US News

Medical Devices
Pharmaceutical and Biologics
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Compounding Crisis
Legislative Update
The Courts
Compliance and Safety Issues
Warning Letters of the Week
Workshops & Meetings
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EU News

Regulation and Guidelines
EMA Information
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