Regulatory Focus: Week in Review (20-24 August)

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.

Top News Items

• Hamburg: Device Approvals Process Set to Become Less Burdensome (Regulatory Focus)
• FDA Releases Guidance on Facility Registrations, Payments Under GDUFA (Regulatory Focus)
• Top FDA Regulatory Official Stepping Down, Will Assume New Duties (Regulatory Focus)
• Bill Proposes National Tracking System for Drug Overdoses (Regulatory Focus)

Regulatory Focus Features

• What RAPS' Scope of Practice Survey Tells Us About the Regulatory Talent Pipeline
• Comparing Drug Master File Procedures in Highly Regulated Markets

US News

• Hamburg: Device Approvals Process Set to Become Less Burdensome (Regulatory Focus)
• FDA Approves 32 New Medical Device Standards (Regulatory Focus)
• Workshop Aims to Assess Emerging Field of Absorbable Medical Devices (Regulatory Focus)
• Coming Next: Using an App as Prescribed (NYTimes)
• Important Information on the Medical Device User Fee Rates for FY 2013 (FDA)

• FDA Changes Regulation to Allow Some Carcinogenic Products to be Used in Animals (Regulatory Focus)
• Citing Consent Decree, Ranbaxy Withdraws Dozens of Generic Drug Registrations (Regulatory Focus)
• Researchers: FDA Needs to Take More Control over Postmarketing Studies (Regulatory Focus)
• FDA Tries to Clear ANDA Backlog before User Fee Assessment (Regulatory Focus)
• FDA Releases Guidance on Facility Registrations, Payments Under GDUFA (Regulatory Focus)
• 31 Drugs Facing FDA Approval in 2012-2013 (The Street)
• FDA calendar crowded with blockbuster decisions for Ironwood, Pfizer and Sanofi (Fierce Biotech)
• "Breakthrough Therapy": New Pathway in FDASIA May Point The Way To Future Reforms (RPM Report)
• FDASIA Study Mandates Focus On Performance, But Could Slow Reviews (The Pink Sheet)
• FDA Dispute Resolution Process Invoked About 10 Times Annually (Pink Sheet Daily)
• Generic Actos gains FDA approval (InPharm)
• Hospira, Inc.; Withdrawal of Approval of a New Drug Application for DEXTRAN 70 (FDA)
• Weighing obesity drugs: Panel ponders what's next (NPR)
• FDA extends review for Pfizer arthritis drug by three months (Reuters)

• Top FDA Regulatory Official Stepping Down, Will Assume New Duties (Regulatory Focus)
• Agency Deficiencies Focus of Newly Proposed Scientific Subcommittee (Regulatory Focus)
• FDA Wants Post-Approval Studies to Address Broader Public Health Needs (Regulatory Focus)
• Regulators to Study use of Composite Scores in Drug Advertising (Regulatory Focus)
• New Center could be Model for Advancing Regulatory Science, Cures (Regulatory Focus)
• In Reversal, FDA to no Longer Publish Agreements in Federal Register (Regulatory Focus)
• Report: Recall Trends Generally Flat Through First Half of Year (Regulatory Focus)
• Which Drugmaker Spends How Much On DTC? (Pharmalot)
• Pharma To CMS: Where's That Sunshine Rule? (Pharmalot)
• U.S. health panel likely to make HIV tests routine (Reuters)

• Legislators Call for Publicly Available 510(k) Database to Address 'Loophole' (Regulatory Focus)
• Bill Proposes National Tracking System for Drug Overdoses (Regulatory Focus)
• Spreading BIO's Message at the National Political Conventions (BIO)
• Startup Innovation Credit Act of 2012 (THOMAS)
• Relative - as Opposed to Absolute - Levels of FDA Funding (FDA Matters)

• Paul Ryan and the Long-Term Outlook for Pharma in Medicare (The RPM Report)
• Why Pharma doesn't want Paul Ryan as V.P.  (Philadelphia Inquierer)
• Paul Ryan and Pharma: The Inside Story (PharmExec)

• Gene Patentability Reaffirmed, But Not Myriad Method Claims (GEN)
• Myriad v. AMP (US District Court of Appeals, NY)
• United Drug asks US Courts to throw out Catalent case (Outsourcing-Pharma)
• Bayer files lawsuit against Warner for infringing patents (PharmaTimes)
• In Litigation Over Animal Feed Antibiotic Withdrawals, District Court Says FDA Needs to Move Forward (FDA Law Blog)

• Medtronic Receives Warning Letter for Alleged CAPA Problems (Regulatory Focus)
• Synthes Hemostatic Bone Putty: Class I Recall - Potential for Putty to Ignite (FDA)
• St. Jude Medical slides on FDA order (Mass Device)
• St. Jude Medical Riata Implantable Cardioverter Defibrillator (ICD) Leads: Safety Communication - Premature Insulation Failure (FDA)
• Hospira Announces A Nationwide Recall Of Three Lots Of Propofol Due To Glass Vial Defect (FDA)
• FDA issues new safety alert on Reumofan Plus and Reumofan Plus Premium (FDA)
• Debarment Orders: Kelly Dean Shrum (FDA)

• Meetings: Generic Drug User Fee Amendments of 2012 (FDA)
• Radiological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting (FDA)
• Gastrointestinal Drugs Advisory Committee; Notice of Meeting (FDA)
• Cardiovascular and Renal Drugs Advisory Committee; Cancellation (FDA)
• FDA Small Business Regulatory Education for Industry (REdI) Conference Fall 2012, September 19-20, 2012 (FDA)

• Study says rare diseases worth the investment (MM&M)
• The Burrill Report (September 2012)
• Top 10 Pharma Firms by Q2 Market Capitalization (GEN)

EU News

• EU Directive Sets Recycling Targets, Shipping Requirements For Med Devices (The Gray Sheet)

• European Medicines Agency closed Monday 27 August (EMA)
• European Medicines Agency recommends limiting long-term use of calcitonin medicines (EMA)

• MHRA Officials Find Suspect Breast Implant Product Rupturing at Accelerated Rate (Regulatory Focus)
• UK to overhaul NICE appeal process following industry pressure (PM Live)
• ABPI sets team for value-based pricing negotiations (BioCentury)
• Skin Tight: A Titillating Ad For An Eczema Cream (Pharmalot)
• EU financial crisis continues to hit drug pricing (Pharma Times)
• New Electrosurgery Device Cleared for NHS Use (Regulatory Focus)

Global Regulatory News

• Australia: TGA Restricts OTC Cough and Cold Medications (Regulatory Focus)
• Canada: Medical Journal Calls for National Approach to Canadian Drug Shortage Crisis (Regulatory Focus)
• Canada Proposes Waiver for Bioavailability Studies (Regulatory Focus)
• Canada: E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting - Reminder for Sponsors (Health Canada)
• Canada: Draft Guidance Document: Guidance on supporting evidence to be provided for Class III and IV in vitro diagnostic device licence applications and amendments (Health Canada)
• Canada: Draft Guidance Document: Preparation of Summary Technical Document (STED)-based Class III and IV Premarket in vitro diagnostic device licence applications and amendments (Health Canada)
• India: Govt plans to introduce 'Uniform Code of Pharmaceutical Marketing Practices' (Hindu Business Times)
• India: Lack of compensation norms for clinical trials results in exploitation of poor patients (The Economic Times)
• India: Linking patented drug price to per capita income may hit generic drug makers: Experts (The Economic Times)
• India: Report: 211 died in Indian trials in first half of 2012 (Fierce CRO)
• India: 1,144 people died during clinical trials in 2010, 2011 (Economic Times of India)
• India: India's Clinical Trial Overhaul (The Scientist)

Important Studies, Whitepapers and Research

• New Study Highlights Dangers of Over-Medicated Seniors (ABC News)
• Study Raises Serious Concerns About Defibrillator Leads (Medical News Today)
• JAMA study: Biodegradable drug-eluting stent safer than bare-metal variety (Fierce Medical Devices)
• Reinventing biopharma: Strategies for an evolving marketplace - Emerging China (Quintiles)
• Will smart pills, cash boost drug compliance? (American Medical News)

Regulatory Reads

• Regulatory staff wages going up despite cost cutting pharma biz, says RAPS (In-Pharma Technologist)
• Changing the FDA's Culture (National Affairs)
• Social Media Compliance Isn't Fun, But It's Necessary (Harvard Business Review)
• FDA Matters: why orphan drugs are a key part of pharma's future (Pharmaphorum)
• Exposing And Eradicating The Dark World Of Fake Pharmaceuticals (Forbes)
• Replacing Cass Sunstein (Center for Regulatory Effectiveness)
• How Sanofi Is Writing The Social Media Rules For Big Pharma Without Running Afoul Of The FDA
• FDASIA, Part 4: Drug Supply Chain, Drug Shortages, and Other Provisions (CATO)
• FDA Proposed UDI: A Revolution In Number Assignment (RxTrace)
• FDA Goals for the Center for Drug Evaluation and Research CDER for FDASIA (Policy and Medicine)
• Regulation and Compliance: Deviation Investigations (Pharmtech)
• Should we regulate the president's regulators? (Washington Post)

Other News and Interesting Reads

• Medical Radiation Soars, With Risks Often Overlooked (NY Times)
• All the Rules, None of the Benefits? Half a Story on Regulation (Demos)
• Macroeconomic Impacts of Federal Regulation of the Manufacturing Sector (MAPI)
• Improving How Agencies Collect Information (RegBlog)
• Testing What We Think We Know (NYTimes)
• Military Plans Mega-Database To Track Human Studies (Forbes)
• Pharma Spending On Outcomes Research Rises (Pharmalot)