Regulatory Focus: Week in Review (10-14 September)
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
- FDA Lays out Plan for National Medical Device Surveillance System (Regulatory Focus)
- Woodcock Proposes Creation of Generics Super Office, New Office of Drug Quality (Regulatory Focus)
- IOM: Regulatory Holds Promise of Improving Healthcare Outcomes (Regulatory Focus)
- FDA: Budget Sequestration Could Lead to 'Loss of Whole User Fee Programs' (Regulatory Focus)
- In Ruling Against KV Pharmaceuticals, FDA's Enforcement Discretion Upheld (Regulatory Focus)
- Health Canada Releases New GMP Inspection Guidance (Regulatory Focus)
Regulatory Focus Features
- Finding Your Pathway Into Regulatory (Regulatory Focus)
- Addressing the Under-representation of Elderly People in Clinical Drug Trials (Regulatory Focus)
US News
Medical Devices- FDA Lays out Plan for National Medical Device Surveillance System (Regulatory Focus)
- FCC Releases Regulations Governing Medical Body Area Network Devices (Regulatory Focus)
- CDRH Revises Standard Operating Procedures for Dispute Resolution (Regulatory Focus)
- Regulatory Considerations of Glaucoma Devices Focus of FDA Meeting (Regulatory Focus)
- Generics Are Coming to the Medical Device Market (MDDI)
- New IEC 60601-1-11 Standard Addresses Home Healthcare Environment (MedTechInsider)
- The FDA Takes On Mobile Health Apps: Regulation is coming soon to health apps. Here's what to expect (IEEE Spectrum)
- Frequently Asked Questions about the New Device Registration and Listing Requirements (FDA)
- FDA Proposed UDI: The GUDID Database (RxTrace)
- Vermont Offers Limited Amnesty to Device and Biologic Manufacturers who Failed to Report Payments to Health Care Providers (Health Industry Watch)
- Woodcock Proposes Creation of Generics Super Office, New Office of Drug Quality (Regulatory Focus)
- FDA Releases Dozens of New, Revised Bioequivalence Draft Guidance Documents (Regulatory Focus)
- FTC Raises Concerns About Quality, Authenticity of Pet Medications (Regulatory Focus)
- Report: Drug Shortages Abating Thanks to FDA Efforts (Regulatory Focus)
- Study: OTC Drug Advertising Lacks Sufficient Balance of Risks, Benefits (Regulatory Focus)
- FDA Slashes Fees for Priority Review Voucher (Regulatory Focus)
- FDA Clears Mayo Clinic to Manufacture PET Drug (Regulatory Focus)
- New MS Drug Receives FDA Approval (Regulatory Focus)
- FDA, USP Devices to Fight Counterfeit Medicines (Regulatory Focus)
- Industry push has made testosterone a blockbuster drug, despite unresolved safety questions (Washington Post)
- New Animal Drugs: Change of Sponsor; Change of Sponsor Address; Lincomycin and Spectinomycin Soluble Powder; Sulfadimethoxine Oral Solution and Soluble Powder; Tiamulin (FDA)
- Pharma Companies Starting To Build Dedicated Digital Marketing/Social Media Staffs (The Pink Sheet)
- Whooping cough vaccine loses punch too fast (Boston Herald)
- IOM: Regulatory Holds Promise of Improving Healthcare Outcomes (Regulatory Focus)
- New Compliance Guide Calls on Veterinary Food Manufacturers to Adhere to Good Practices (Regulatory Focus)
- FDA Science Board Seeks New Members (Regulatory Focus)
- FDA Debars Two for Falsifying Clinical Trial Data (Regulatory Focus)
- AHRQ Plans Patient-Based Adverse Event Reporting System (Regulatory Focus)
- Consortium Brings Together FDA, Industry to Release New Data Reporting Standard (Regulatory Focus)
- The FDA Turns Friendly Toward Pharma in 2012 (Xconomy)
- OSC concludes Hatch Act investigation of Sebelius (NioCentury)
- Consolidation of Seizure and Forfeiture Regulations (DEA)
- FDASIA Has Low Profile in Pharma Earnings Calls (RPM Report)
- FDA: Budget Sequestration Could Lead to 'Loss of Whole User Fee Programs' (Regulatory Focus)
- Legislation Would Keep FDA Budget at 2012 Levels Through March (Regulatory Focus)
- Bill Curtailing FDA Conference Spending Passes House (Regulatory Focus)
- Hamburg Speaks on Effect of Sequester on User Fees (Alliance for a Stronger FDA)
- Obama and Romney tackle 14 top science questions (Nature)
- Election Scenario For Senate HELP Committee (The Pink Sheet)
- HHS Secretary Sebelius found in violation of Hatch Act (Federal Times)
- In Ruling Against KV Pharmaceuticals, FDA's Enforcement Discretion Upheld (Regulatory Focus)
- DePuy execs to testify in hip implant recall trials (Mass Device)
- Stryker faces more lawsuits over hip implants (Fierce Medical Devices)
- Cosmetic Company L'Oreal Hit by Warning Letter for Questionable Claims (Regulatory Focus)
- Warning Letter to Eli Lilly Focuses on Use of Color Images in Marketing Materials (Regulatory Focus)
- FDA Cracks Down On Unregistered Foreign Pharmaceutical Manufacturers (The Pink Sheet Daily)
- Qualitest Hydrocodone Bitartrate and Acetaminophen Tablets 10 mg/500 mg: Recall - Potential for Oversized Tablets
- Anti-Infective Drugs Advisory Committee; Notice of Meeting (FDA)
- Overcoming Statistical Challenges to the Reuse of Data within the Mini-Sentinel Distributed Database (Brookings)
- Brookings Council on Antibacterial Drug Development Meeting #1 (Brookings)
- Pharma deals during August 2012 (PMLive)
- Bayer buys Teva animal health unit (PMLive)
EU News
Regulation and GuidanceEMA Information- EMA Updates Its Fee Structure Guidance (Regulatory Focus)
- EMA to Engage in Cooperative Activities with European Drug Monitoring Agency (Regulatory Focus)
- EMA Appoints Leaders of Newly-Formed Pharmacovigilance Committee (Regulatory Focus)
- EMA wants pharma to see commercial potential in paediatric R&D (PMLive)
- Stella Blackburn appointed president of the International Society for Pharmacoepidemiology (EMA)
- UK: MPs plan "short" probe into NICE (PharmaTimes)
- EC GMP revisions have implications for CMOs (Outsourcing Pharma)
- Talking point: Skin and bones (EuroParlTV)
- UK: The future of specialised services outlined in report (UK DOH)
Global Regulatory News
- Australia Planning Updated GMPs for Blood and Tissue Products (Regulatory Focus)
- Health Canada Releases Planned Overhaul of Vigilance System (Regulatory Focus)
- Health Canada Releases New GMP Inspection Guidance (Regulatory Focus)
- Health Canada Overhauls Guidance for eCTD Module (Regulatory Focus)
- Brazil: Regulators Partner With Government to Advance Regulatory Science (Regulatory Focus)
- Indian Court To Novartis: Lower Gleevec Price (Pharmalot)
- India: Government proposes measures to curb spurious drugs in market (The Economic Times)
- Japan: PMDA Provides Updated Guidance on Conducting Global Clinical Trials (Regulatory Focus)
Important Studies, Whitepapers and Research
- Who Can Buy Drugs During A Sour Economy? (Pharmalot)
- Most Prescription Drugs Available In Canada Are Manufactured Overseas -- Are They Safe? (Medical News Today)
- Measuring Regulatory Performance: Evaluating the Impact of Regulation and Regulatory Policy (OECD)
- Measuring Regulatory Performance: Evaluating Regulatory Management Tools and Programmes (OECD)
- 2012 Patent Litigation Study (PWC)
- Strategy developed to improve delivery of medicines to the brain (NIH)
- Misrepresentation of Randomized Controlled Trials in Press Releases and News Coverage: A Cohort Study (PLoS)
- Invisible Quick-Response Codes (the Square Ones) Could Thwart Counterfeiting (Scientific American)
Regulatory Reads
- The Stunning Triumph of Cost-Benefit Analysis (Bloomberg)
- The Big Sell: Biologics In Emerging Markets (PharmExec)
- Managing Risk: GMPs are not Enough (PharmaManufacturing)
- Four Steps to Managing Supplier Quality (PharmaManufacturing)
- Flacking for Big Pharma (Flacking for Big Pharma)
- Regulatory Challenges in the QbD Paradigm (Biopharm International)
- Maximizing REMS potential (REMS)
- Are Drug Pipelines Really Getting Better? (Pharmalot)
- What's the Difference between a Regulatory Strategy and a Regulatory Plan? 5 Questions with Michael Santalucia (MDDI)