Regulatory Reconnaissance (19 September 2013)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Tips? Gripes? Let me know: [email protected].

In Focus: US

• FDA's supply chain security pilot gets underway (Securing Industry)
• CDER's Pharmaceutical Quality Office Expected To Launch In Early 2014 (Pink Sheet)
• FDA To Reorganize Device Center Compliance Office (IHP)
• Apple now asking app developers to provide sources of medical information (iMedicalApps)
• OMB to FDA: Start Planning for Government Shutdown (OMB) (FedNewsRadio) (Federal Times)
• FDA final guidance on eCRFs skirts questions raised by ACRO, Quintiles (Outsourcing Pharma)
• Medical Food Mumbo Jumbo: Confusing FDA Guidance Documents Will Discourage Medical Food Development (FDA Law Blog)

In Focus: International

• WHO Forming Strategic and Technical Advisory Group to Address Antimicrobial Resistance (WHO)
• No to EU scrutiny procedure and PMA, but compromise will not float industry's boat (Clinica)
• Will German Regulators Dampen Gilead Hopes For Its Stribild AIDS Drug? (Forbes)
• Tech firms, medical research threatened by helium shortage (Reuters)

Comments? Suggestions? Email me at [email protected].

US: Pharmaceuticals/Biotechnology

• PhRMA, BIO, Amgen comment on REMS standardization (BioCentury)
• FDA's supply chain security pilot gets underway (Securing Industry)
• CDER's Pharmaceutical Quality Office Expected To Launch In Early 2014 (Pink Sheet)
• What Hurt Ranbaxy? Hair, Oil Spots And Bathrooms Without Water (Pharmalot)
• How FDA uses dose-response curve to evaluate LABAs for pulmonary disorders (BioCentury)
• Ranbaxy's Failure To Strike At Root Cause Triggered U.S. FDA's Import Alert On Mohali Site (PharmAsia)
• CDISC and TransCelerate BioPharma Inc. Announce Landmark Asthma Data Standard Released for Public Review (CDISC)
• FDA final guidance on eCRFs skirts questions raised by ACRO, Quintiles (Outsourcing Pharma)
• Genentech's Perjeta provides lessons for followers in neoadjuvant breast cancer (BioCentury)
• FDA Approves NDA for Pfizer's Axitinib (#202324) (FDA)
• FDA Approves NDA for Roxane's Cyclophodphamide (#203856) (FDA)
• CDER Quality Agreement Guidance Instructive For Supplement GMPs (Pink Sheet)
• NIH begins testing H7N9 avian influenza vaccine candidate (NIH) (EurekAlert) (SCRIP) (BioCentury)
• California to amend track and trace law to deal with 'drop shipments' (In-Pharma)
• High Court Urged Not To Take Novo Foreign Liability Case (Law 360)
• Jazz Pharma Sues Amneal Over Generic Narcolepsy Drug (Law 360)
• Inhaled corticosteroids raise pneumonia risk (EurekAlert)

US: Pharmaceuticals and Biotechnology: General

• NIH funding boosts new Alzheimer's research by $45 million (NIH) (PMLive) (BioCentury)
• Opinion: Bring Back the Lyme Vaccine (NYTimes)
• MIT team gets $10.4M to make biologic drugs quickly for battlefield use (BioFlash)
• Soligenix Awarded BARDA Contract Valued up to $26.3 Million for Advanced Development of OrbeShield in GI ARS (Soligenix)

US: Medical Devices

• Opthalmic Devices Panel Considers Ocular Therapeutix' ReSure Sealant (Gray Sheet)
• FDA To Reorganize Device Center Compliance Office (IHP)
• Apple now asking app developers to provide sources of medical information (iMedicalApps)
• GE issues another imaging system fall warning after discovering missing screws (Mass Device)
• Profound Medical lands FDA OK for prostate cancer trial (Mass Device)

US: Assorted And Government

• OMB to FDA: Start Planning for Government Shutdown (OMB) (FedNewsRadio) (Federal Times)
• House Raises Spectre of Government Shutdown Occuring, Linking Budget to Obamacare Defunding Measure (SCRIP) (AP) (The Hill) (WSJ)
• Rep. Yarmuth Replaces Ed Markey on House Energy and Commerce Committee Subcommittee on Health (House)
• MODDERN Cures Act of 2013 Introduced in House (Congress)
• House Small-Business Panel OKs GOP Regulatory Reform Bill (Law 360)
• Medical Food Mumbo Jumbo: Confusing FDA Guidance Documents Will Discourage Medical Food Development (FDA Law Blog)
• Reporting of Serious Adverse Events for Dietary Supplements and OTC Drugs - A Simple Idea (Lachman)
• Facebook 'Likes' Are Protected by First Amendment (WSJ)
• Transparency Withdrawn: A New Tactic for Shielding OIRA's Regulatory Review Activities? (CPR)

Upcoming Meetings And Events

• 16 September 2013: Brookings Roundtable on Active Medical Product Surveillance (FDA)
• 18 25 September 2013: ENVI Meeting on Medical Device Proposals (ENVI)
• 18-19 September 2013: The Patient Preference Initiative: Incorporating Patient Preference Information into the Medical Device Regulatory Processes (FDA)
• 19 September 2013: Ophthalmic Devices Panel of the Medical Devices Advisory Committee Meeting (FDA)
• 19-20 September 2013: Pediatric Advisory Committee Meeting  (FDA) (FDA)
• 19-20 September 2013: Meeting on Proposed Foreign Supplier Verification Programs (FDA)
• 24 September 2013: Public Meeting on Narcolepsy Patient-Focused Drug Development (FDA)
• 25-26 September 2013: FDA Small Business Regulatory Education for Industry Conference (FDA)
• Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

• No to EU scrutiny procedure and PMA, but compromise will not float industry's boat (Clinica)
• Will German Regulators Dampen Gilead Hopes For Its Stribild AIDS Drug? (Forbes)
• EFPIA: Clinical Trial Data is Not a "Public Good" (EFPIA)
• Europe: Still An Attractive Place for Clinical Trials? (PharmExec)

Asia

• India Presses Russia To Ease Lengthy, Costly Drug-Registration Process (PharmAsia)

Other International

• WHO Forming Strategic and Technical Advisory Group to Address Antimicrobial Resistance (WHO)
• Panacea's pentavalent vaccine set to regain WHO prequalification (SCRIP) (India Times)
• Australia: Software as in vitro diagnostic medical devices (IVDs) (TGA)

General Regulatory And Interesting Articles

• Analysis: Tech firms, medical research threatened by helium shortage (Reuters)
• Viral or bacterial? New test aims to let doctors know quickly (NBC)
• Gene discovery could lead to new types of HIV treatments (Reuters)

Regulatory Reconnaissance #158 - 19 September 2013

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].