Regulatory Reconnaissance (15 February 2013)

Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory news stories from around the globe.

US

• FDA Panel Rejects Guerbet's Imaging DrugDotarem For Young Children (Pink Sheet Daily)
• Teva warns could face legal costs of $2.07 billion over generic exclusivity (Reuters)
• U.S. appeals court finds Astra's Seroquel XR patent infringed by Mylan (Reuters) (AstraZeneca)
• Merck settles lawsuits over cholesterol drug for $688 million (AP) (WSJ) (Merck)
• NABP Member Boards Take Action to Strengthen Regulation of Compounding Practice (NABP)
• Drug Shortage Oversight Remains Key GAO Concern As FDA Is Again Deemed "High-Risk" (Pink Sheet Daily) (Report)
• Meetings: Circulatory System Devices Panel of the Medical Devices Advisory Committee (FDA)
• Meetings: Transmissible Spongiform Encephalopathies Advisory Committee (FDA)
• Revisions to Chapter 3 of FDA's Regulatory Procures Manual (FDA)
• FDA grants orphan status to Eisai cancer drug (Biospectrum)
• US Marshals seize drug products distributed by a Florida company (FDA)
• Call for track and trace resurrected in face of more counterfeits (Fierce Pharma Manufacturing)
• Orrin Hatch, AbbVie & Lobbying The Global Fund (Pharmalot)
• Class I Recall: Lumenis Ltd.'s VersaCut Tissue Morcellator (FDA)
• Class I Recall: GE Healthcare's T-Piece Resuscitation Systems and Mask Resuscitation Systems (FDA)
• FDA warns Bacterin over bone putty, wound drain product production (Fierce Medical Devices)
• December 2012 PMA Approvals (FDA)
• FDA Sends More GMP-Related Warning Letters to Four Dietary Supplement Manufacturers (Nutraingredients USA)
• FDA Furloughs Likely Under Sequestration (FDA News) ($)
• Dems introduce plan to again delay sequestration (BioCentury) (The Hill)
• WellPoint uses Watson to speed up pre-approval process (Fierce Health Payer)
• Public Citizen: FDA Should Require Intra-Aortic Balloon Pumps to Be Tested in People for Safety and Effectiveness (Public Citizen)

International

• J&J again recalls thousands of faulty hip implants (AP) (Reuters)
• Egypt Drafts Biosimilars Guidelines (Biosimilar News)
• NHRC's notice to health ministry for 'illegal' trials on children without parents' consent (PharmaBiz)
• Australian drugmakers clash over generics proposal (Pharma Times)
• Meeting: EU 28: science, medicines, health - a regulatory system fit for the future (EMA)
• Meeting: ENVI Workshop on Medical devices and In Vitro Diagnostic Medical Devices (ENVI)
• Herbal medicines - strengthening assessment methodology and releasing summaries for the public (EMA)
• Aus vaccine firm helps US army fight bio-terrorism (Biospectrum Asia)
• Takeda, CMO hit with sanctions by Japanese regulator (Fierce Pharma Manufacturing)

Interesting

• Can the FDA Ban Cupcakes? (Harvard Bill of Health)
• Restoring Confidence in the Pharmaceutical Industry (JAMA)

Did we miss a story? Send us a tweet at @RAPSorg or @AlecGaffney and we'll check it out for inclusion in our next edition of Regulatory Reconnaissance.