Regulatory Reconnaissance: Daniel Fabricant, Top Supplement Regulator, Leaving FDA (8 April 2014)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Read anything we might be interested in sharing? Let us know: [email protected].

In Focus: US

• Daniel Fabricant, Head of Supplements at FDA, Leaving to Head NPA (Nutraingredients-USA)
• $9B Verdict Hammers Takeda, Eli Lilly In Actos Bellwether (Law 360-$) (Takeda) (Reuters) (Guardian) (PMLive) (NYTimes) (Bloomberg)
• Zogenix takes Massachusetts to court over Zohydro ban (SCRIP-$) (The Hill) (Boston Herald) (Reuters) (BioCentury-$)
• FDA, DEA Drafting Agreement To Share Information On Controlled Substances (Pink Sheet-$) (SCRIP-$)
• Women's groups are calling the FDA sexist for not approving female Viagra. Why They're Wrong. (Slate)
• AdvaMed Tags China-Made Device Knock Offs As Concern At Federal Commission Hearing (Gray Sheet-$)
• FDA Action Urged On Usability Testing In Elderly, Minority Patients For Self-Management Devices (Gray Sheet-$)

In Focus: International

• EMA slashes fees for small drug developers (In-Pharma)
• New standard brings labelling clarification for medical devices used in MR setting (Clinica-$)
• A 'qualifier' for all biologics could solve biosimilar INN dispute (SCRIP-$)
• Did Regulatory Issues Finally Lead Daiichi Sankyo to Cut its Losses With Ranbaxy? (India Times)
• Sun Pharma's $3.2bn Ranbaxy acq: 'Compliance first, synergies later' (In-Pharma) (Bloomberg)

US: Pharmaceuticals/Biotechnology

• $9B Verdict Hammers Takeda, Eli Lilly In Actos Bellwether (Law 360-$) (Takeda) (Reuters) (Guardian) (PMLive) (NYTimes) (Bloomberg)
• Zogenix takes Massachusetts to court over Zohydro ban (SCRIP-$) (The Hill) (Boston Herald) (Reuters) (BioCentury-$)
• FDA, DEA Drafting Agreement To Share Information On Controlled Substances (Pink Sheet-$) (SCRIP-$)
• FDA: We're Working Closely with Manufacturers of Meningitis B Vaccines (FDA)
• Teva Asks Supreme Court To Block Generic MS Drugs (Law 360-$) (Reuters) (SCOTUSblog)
• FDA Policies in Place, DIY Fecal Transplants on the Rise (Medpage Today)
• CDER urgently recruiting senior managers from industry to replenish top staff (BioCentury-$) (BioCentury-$)
• On the Merits of the Expanded Access Program (DrugWonks)
• Women's groups are calling the FDA sexist for not approving female Viagra. They're wrong. (Slate)
• FDA patient workshop show pain management still unmet need in fibromyalgia (BioCentury-$)
• FDA: Symptoms are key efficacy domain in CFS, but endpoints still unknown (BioCentury-$)
• Merck Accuses Expert Of Leaking Confidential Vioxx Docs (Law 360-$)
• Teva Announces First Approval and Launch of Generic Lovaza Capsules in the United States (Press)
• Sun's Ranbaxy Buy Out Could Have Implications For Nexium Generics (Pink Sheet-$)
• Quebex-based Macco Organiques Brought off Import Alert (FDA)
• Law Proposes ID Protocols for Biological Implants Used by the VA (Congress)

US: Pharmaceuticals and Biotechnology: Clinical Study Results, Filings and Designations

• Alkermes hits PhIII goal line with 'blockbuster' long-acting schizophrenia drug (Fierce) (Press) (Reuters)
• US: Pharmaceuticals and Biotechnology: General
• To spark cancer discoveries, several Big Pharma companies are sharing idle clinical trial data (MedCityNews)
• States look to naloxone to cure America's overdose epidemic (Guardian)
• Controversy Erupts Over HIV Prevention Drug (AP)
• $5.6 Billion Questcor Deal Means High Drug Prices For Everybody (Forbes)

US: Medical Devices

• AdvaMed Tags China-Made Device Knock Offs As Concern At Federal Commission Hearing (Gray Sheet-$)
• FDA Action Urged On Usability Testing In Elderly, Minority Patients For Self-Management Devices (Gray Sheet-$)
• Payor Coverage of Medical Devices Approved Under FDA's Humanitarian Device Exemption (Pew)
• Device Company Scanadu Selling its Non-FDA-Approved Device as RUO (MobiHealthNews) (RUO Guidance)
• ReliantHeart goes head-to-head with Thoratec to aim for U.S. LVAD market (Mass Device)
• Report: Healthcare Cybersecurity Appalling, Legislation Not Enough (MDDI)
• Fearing Punishment for Bad Genes (NYTimes)

US: Dietary Supplements

• Fabricant leaves FDA, replaces Shaw as head of NPA (Nutraingredients-USA)
• Does FDA Have Authority to Impose IND Requirements on Non-Drug Studies? (FDA Law Blog)
• US: Assorted And Government
• Can You Patent A Natural Product? Prepare For a Different Answer (In The Pipeline)
• NRDC Criticizes FDA GRAS Process for New Food Ingredients (NPI)

Europe

• EMA slashes fees for small drug developers (In-Pharma)
• New standard brings labelling clarification for medical devices used in MR setting (Clinica-$)
• CT regulation cleared by Parliament with CCI exemption intact (Pharma Times)
• New Edition of EU Blue Guide-Implementation of EU Product Rules-Arrives (MedDevLegal)
• Online Patient Library Set for European Launch (PharmExec)
  

India

• Did Regulatory Issues Finally Lead Daiichi Sankyo to Cut its Losses With Ranbaxy? (India Times)
• Sun Pharma's $3.2bn Ranbaxy acq: 'Compliance first, synergies later' (In-Pharma) (Bloomberg)
• Local Indian Regulators Working to Crack Down on Illegal Online Drug Retails (PharmaBiz)

Other International

• A 'qualifier' for all biologics could solve biosimilar INN dispute (SCRIP-$)
• Australia: Upgraded over-the-counter medicines online application system (TGA)

General Regulatory And Interesting Articles

• Increased Patient Adherence: As Simple as Giving Patients Better Information in Drug Packaging (EyeForPharma)
• Spinal stimulation helps 4 patients with paraplegia regain voluntary movement (Press) (NBC) (AP)
• How Mouse Studies Lead Medical Research Down Dead Ends (NPR)
• Antidepressants Linked to Premature Births (NYTimes)
• Triclosan from soaps found to promote bacteria buildup in human noses (Press)

Regulatory Reconnaissance #293 - 8 April 2014

Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory news stories from around the globe. Each weekday morning, we aim to bring you the latest highlights of new approvals, meetings, legal and political developments, regulations and guidance, and the latest trends with the potential to impact regulatory affairs professionals and the industry in which they work.

Did we miss a story? Send us a tweet at @RAPSorg and we'll check it out for inclusion in our next edition of Regulatory Reconnaissance. Want this in your inbox each morning? Sign up for RF Today, our morning intelligence newsletter here.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @AlecGaffney or send him an email at [email protected].