Regulatory Focus: Week in Review (30 July - 3 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

• US, Canada Announce Extensive New Harmonization Efforts (Regulatory Focus)
• User Fees Published for Drugs, Biosimilar Products (Regulatory Focus)
• Upcoming Medical Device User Fees Unveiled (Regulatory Focus)
• Is FDA on Pace to Beat Its 2011 Drug Approval Numbers? (Regulatory Focus)
• OMB to Federal Agencies: Begin Planning for Massive Budget Cuts (Regulatory Focus)
• EU Regulators Expand Electronic Submission Program, Recommend Wider Use (Regulatory Focus)
• GHTF Releases Guidance on Adverse Event Data Reporting Standard (Regulatory Focus)

Regulatory Focus Features

• The Problem with Audit Reports (Regulatory Focus)
• Orange Book Listings Lesson: An overly broad use code may lead to legal challenges (Regulatory Focus)
• Op-ed: New RAPS Research on the Regulatory Profession (Regulatory Focus)
• Voluntary Harmonization Process for Multinational Clinical Trials in the EU (Regulatory Focus)

US News

Medical Devices

• Upcoming Medical Device User Fees Unveiled (Regulatory Focus)
• Study: Who Regulates Medical Devices Better: US or EU? (Regulatory Focus)
• Study: US Beats EU in Speed to Market Thanks to Reimbursement Process (Regulatory Focus)
• Filing Review Process to See Changes Under Proposed CDRH Guidance (Regulatory Focus)
• FDA Clears Ingestible Medical Device Aimed at Boosting Adherence (Regulatory Focus)
• FDA Final Rule Mandates Electronic Registration of Device Establishments (Regulatory Focus)
• FDA Official Is Arrested For Soliciting Prostitutes (Pharmalot)
• 23andMe seeks FDA approval for personal DNA test (Boston Herald)
• FDA Approves Robotic System To Open Your Arteries (Forbes)
• Move by Cardinal Health May Signal Growth of Generic Medical Devices Market (MDDI)

Pharmaceutical and Biologics

• Is FDA on Pace to Beat Its 2011 Drug Approval Numbers? (Regulatory Focus)
• FDA Adopts ICH Guidance on Pharmaceutical Quality (Regulatory Focus)
• User Fees Published for Drugs, Biosimilar Products (Regulatory Focus)
• Regulatory Bodies to Assess Alternate Vaccine Testing Methods (Regulatory Focus)
• FDA Wants More Data on Antibiotics (Regulatory Focus)
• US Court: Stem Cells may be Regulated as Drugs (Regulatory Focus)
• Revised FDA Manual Provides Statistical Reviewers with Standardized Template (Regulatory Focus)
• FDA's Opioid Control Plan Slammed (Med Page Today)
• New Weight-loss Drugs Offer Promise in the Fight Against Obesity, But They're Not for Everyone (FDA)
• Prescription drug monitoring system running low on funds (California Watch)
• Bristol-Myers Suspends Hepatitis C Drug Clinical Trial (Bloomberg)
• Pfizer CEO: FDA May Need More Time to Review Tofacitinib Application (WSJ)
• FDA Solicits Comments Related to the Collection of Sales and Distribution Data of Antimicrobial Animal Drugs (FDA)
• Drug Sample Reporting Must Be Streamlined, PhRMA Tells FDA (The Pink Sheet)
• Fitch predicts 2012 dip in US drug approvals as wave of generics, other issues cut sales (Washington Post)
• Faced with shortages, paramedics turn to expired drugs (AHCJ)

Other US News

• US, Canada Announce Extensive New Harmonization Efforts (Regulatory Focus)
• OMB to Federal Agencies: Begin Planning for Massive Budget Cuts (Regulatory Focus)
• Report: Tainted Blood Platelets Pose Greater Risk than HIV-Infected Blood Products (Regulatory Focus)
• Desperately Seeking A Quality Control Director (Pharmalot)
• POM Wonderful Says Interviews Fall Outside FTC Advertising Scope (The Pink Sheet Daily)
• Caustic Crusader at Center of F.D.A. Scandal (NYTimes)
• A Lonely Voice Asking Tough Questions on Cancer Cost-Effectiveness (Xconomy)
• Ohio Tries High-Tech Tactics to Fight Painkiller Abuse (WSJ)
• FDA Voice Interviews Michelle Yeboah, Dr.P.H., Director of FDA's Office of Minority Health (FDA)
• NIH creates Office of Emergency Care Research (NIH)

Legislative Update

• New House Bill Would Allow Manufacturers to Label Products 'Cancer-Free' (Regulatory Focus)
• New Bill Seeks to Overturn EPA, FDA Ban of OTC Inhalers (Regulatory Focus)
• Senator Calls on Agencies to Investigate FDA Surveillance Activities (Regulatory Focus)
• Legislators, Regulators to Enhance Regulation of Anabolic Steroids (Regulatory Focus)
• US Legislators Reportedly Close to Deal to Prevent Government Shutdown (Regulatory Focus)
• Legislation Would Subject FDA Information Inquiries to Performance Standards (Regulatory Focus)
• Proposed Bill Exempts Minor First-Time Regulatory Violations from Civil Fines (Regulatory Focus)

The Courts

• Responsible Corporate Officer Doctrine Upheld by Appeals Court (Regulatory Focus)
• For Big Drug Companies, a Headache Looms (The New York Times)
• Jury finds Bard, surgeon, liable in vaginal mesh lawsuit (Fierce Medical Devices)
• Appeals Court Sides with Women Who Took Prempro (PharmPro)
• Par Pursuing Settlement Of FDA Suit And DoJ Off-Label Investigation (The Pink Sheet Daily)
• Synthes sued for wrongful death, fraud in illegal bone cement trial (Philly Pharma)

Compliance and Safety Issues

• GlaxoSmithKline chief apologises after company fined for mis-selling (The Guardian)
• J&J expects consent decree to extend through 'most of 2013' (InPharm)
• FDA lifts ban on Dr. Reddy's imports from Mexico (Fierce Pharma)
• FDA Finds 483 Reponses Lacking (Natural Products Insider)
• Olympus slapped with DOJ inquiries, Terumo shareholder lawsuit (Fierce Medical Devices)
• Warning Letter: United Nutrition Labs, Inc. 7/24/12 (FDA)
• Warning Letter: Sybron Dental Specialties 7/17/12 (FDA)
• Warning Letter: Community Blood Centers of Florida, Inc. 4/27/12 (FDA)
• Enforcement Report - Week of August 1, 2012 (FDA)
• B. Braun Infusomat Space Infusion System - Expansion of Recall from January, 2012 (FDA)
• Class 1 Recall: Medfusion® 4000 V1.0 &V1.1 Syringe Infusion Pump (FDA)
• Class 1 Recall: CareFusion Alaris PC Unit, Model 8015 (FDA)
• OTC DRUG Nationwide Recall -- Benzalkonium Chloride Antiseptic Wipes (FDA)
• Arrow International, Inc. Multi-Lumen Venous Catheterization Set with Blue FlexTip ARROWg+ard Catheter: Class I Recall - Contains Unlabeled Drug Ingredient (FDA)

Workshops & Meetings

• FDA to Assess New Regulatory Endpoints for Four Disease Areas (Regulatory Focus)
• Blood Products Advisory Committee; Notice of Meeting (FDA)
• Pediatric Advisory Committee; Notice of Meeting (FDA)
• Workshops: Statistical Process Controls for Blood Establishments (FDA)
• Public Workshop - ASTM-FDA Workshop on Absorbable Medical Devices: Lessons Learned from Correlations of Bench Testing and Clinical Performance, November 28, 2012 (FDA)
• Sharing Clinical Research Data: A Workshop (IOM)
• Workshop on Glutamate-related Biomarkers in Drug Development for Disorders of the Nervous System (IOM)
• Workshop on CNS Clinical Trials: Suicidality and Data Collection (IOM)
• International Workshop on Alternative Methods for Leptospira (DHHS)

EU News

• Draft Guideline on Labeling Immunoglobulin Products Released by EMA (Regulatory Focus)
• EU Regulators Expand Electronic Submission Program, Recommend Wider Use (Regulatory Focus)
• EMA Looks to Allow More Regulatory Flexibility for Pediatric Plan Submissions (Regulatory Focus)

EMA Information

• EMA Phasing Out Follow-Up Measures (Regulatory Focus)
• EMA Calls for Further Research on Personalized Approaches to Treating Hemophilia (Regulatory Focus)
• EU's newly-changed rules on cGMP certificate for bulk drug exports may hit Indian exports (PharmaBiz)
• EU OKs Vertex cystic fibrosis drug Kalydeco (Fierce Pharma)
• 2012 Report on the State of the Art of Rare Disease Activities in Europe (EUCERD)
• Report available on activities on medicines for children during 2011 (EMA)
• European Medicines Agency workshop with European Union pharmaceutical industry associations on the implementation of Article 57(2), second subparagraph of Regulation (EC) No. 726/2004 (EMA)
• Questions and answers on practical transitional measures for the implementation of the pharmacovigilance legislation (EMA)
• European Medicines Agency sees benefits of interaction with Japanese regulators (EMA)

Other EU News

• NICE Restricts GE's Diagnostic Test to Research Use (Regulatory Focus)
• NICE Clears New Colposcopy Device for NHS Use (Regulatory Focus)
• EU fake medicine seizures soar 700 per cent in 2011 (Securing Pharma)
• UK: New UK drug pricing system will 'stifle innovation' (InPharm)
• UK: Bayer guilty of multiple Code breaches (InPharm)
• UK: Animal activists' terror tactics drive staff out of laboratories (The Guardian)
• Developments in the creation of a single EU Patent System stalled - Again. (BiotechNOW)

Global Regulatory News

• Brazilian Consumers Allowed to Purchase OTC Drug Products Under New Rules (Regulatory Focus)
• Canada: Notice - 2012 Annual Drug Notification and Fee Remission Request (Health Canada)
• Canada: Canada's health ministers call for VBP for generics (PharmaTimes)
• Canada: New Safety Labeling Guidance for Aspirin Products (Regulatory Focus)
• Canada: Notice - Annual Drug Notification package is now being sent electronically (Health Canada)
• Canada: Bad Science Watch to Health Canada: De-register Homeopathic Vaccines (Bad Science Watch)
• China source of most counterfeit in EU (FT)
• Conformity assessment for standards writers (ISO)
• GHTF Releases Guidance on Adverse Event Data Reporting Standard (Regulatory Focus)
• India: Report: 438 died in Indian clinical trials last year (Fierce CRO)
• Harmonization Fail: ICH Guideline Doesn't Simplify Safety Reporting, Firms Say (The Pink Sheet)
• New ISO standard to help protect people against sun damage to the skin (EMA)
• WEEE2 Directive Puts Medical Device Industry on Notice (Medtech Insider)

Important Studies, Whitepapers and Research

• New Portable Anti-Counterfeiting Technology Promises 'Paradigm Shift' (Regulatory Focus)
• 2012 Food and Drug Administration Safety and Innovation Act (PWC)
• What Value-Based Health Care Means for Pharma (BCG)
• Scientists Engineer "Chimera" Primates to Combat Human Ailments (PopSci)
• New Algorithm Will Change How Scientists Build Networks From Data To Help Predict Gene And Drug Interactions (Medical news Today)
• Poor Sleep Can Reduce Effectiveness Of Vaccines (Medical Daily)
• Study: Discovering new uses for old drugs (EurekAlert)
• FDASIA, Part 2: Pediatric Drugs and Devices and Medical Device Regulatory Improvements (Ask CATO)

Regulatory Reads

• FDA, Revisit Your Sampling Guidance! (PharmaManufacturing)
• The formation of the EMA (PM Live)
• Overcoming Fraudulent Allegations of Health Care Fraud (Medical Progress Today)
• Should the FDA Regulate Recreational Drugs? (TIME)
• Is Flexible Regulation an Oxymoron? (The Center for Regulatory Effectiveness)

Other News and Interesting Reads

• The Great Unmentionable: The role of high salaries and wages in health care inflation (The Weekly Standard)
• Infographic: America's High Health Care Costs (Center for American Progress)