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Regulatory Focus: Week in Review (6-10 August)

Latest News | Posted: 10 August 2012

By Alexander Gaffney

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.

Previous Week in Reviews: [30 July – 3 August] [23-27 July] [16-20 July] [18-22 June] [11-15 June] [4-8 June][21-25 May] [14-18 May]

Top News Items

• FDA Looking to Overhaul Compliance Approach (Regulatory Focus)
• Indian Regulators Release Draft Clinical Trial Rules (Regulatory Focus)
• 'Major Updates' to eCTD Module 1 Released by FDA (Regulatory Focus)
• China Rule Puts Primary Responsibility for Excipient Quality on Drug Manufacturers (Regulatory Focus)
• EU Science Agency Calls for Experts, Information on Host of Medical Device Safety Issues (Regulatory Focus)

Regulatory Focus Features

• Enforcement Trends Reveal Record-High Warning Letter Issuances, Common Violations (Regulatory Focus)
• What RAPS' Scope of Practice Survey Tells Us About the Regulatory Talent Pipeline (Regulatory Focus)
• Comparing Drug Master File Procedures in Highly Regulated Markets (Regulatory Focus)
• Tarantulas: Possible Lifesavers? (Regulatory Focus)

US News

Medical Devices

• FDA Looking to Overhaul Compliance Approach (Regulatory Focus)
• Will CDRH Soon be Reviewing Video Games? (Regulatory Focus)
• Could Radiation Exposure Recommendations Affect an Impending App Guidance? (Regulatory Focus)
• Genetic testing company 23andMe seeks credibility boost with FDA application (Washington Post)
• Abbott nets FDA clearance for Omnilink stent for iliac artery disease (Cardiovascular Business)
• Biometric Bracelet Lets a Medical Device Recognize its Wearer (Technology Review)
• FDA Safety Communication: Narrowed Indications for Use for the Stryker Wingspan Stent System (FDA)

Pharmaceutical and Biologics

• 'Major Updates' to eCTD Module 1 Released by FDA (Regulatory Focus)
• CDER on Pace to Release 61 New and Revised Guidance Documents in 2012 (Regulatory Focus)
• FDA: Send Us Your Pediatric Oncology Drugs (Regulatory Focus)
• Former FDA Official Slams Regulation of Stem Cells as Exceeding Agency Authority (Regulatory Focus)
• GPhA: 505(j) Provisions Saved US $1 Trillion Since 2002 (Regulatory Focus)
• Blockbuster Asthma Drug Singulair Receives Generic Competition (Regulatory Focus)
• New Colorectal Cancer Therapy Approved by FDA (Regulatory Focus)
• Experts Fear Whooping Cough Vaccine's Shield Is 'Waning' (NPR)
• FDA Radioactive Drug Research Committee Program Presentations and Publications  (FDA)
• Dissolution Tests As A Drug Development Tool: Concept Gets FDA Panel Review (The Pink Sheet Daily)
• New Animal Drugs: Cephalexin; Fentanyl; Milbemycin Oxime and Praziquantel (FDA)
• FDA Admits It Has Yet To Fill In Big Gaps On Biosimilar Regs (Law 360)
• Proposed Aggregate Production Quotas for Schedule I and II Controlled Substances and Proposed Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2013 (DEA)

Other US News

• Report: Monitoring Scandal Involves Top FDA Officials (Regulatory Focus)
• Director of OIRA to Step Down at End of August (Regulatory Focus)
• Industry Program Aimed at Preventing Drug Shortages Obtains FTC Approval (Regulatory Focus)
• Simpler, More User-Friendly Forms Coming to FDA (Regulatory Focus)
• FDA, Data Standard Groups Promote Adoption of EHRs (Regulatory Focus)
• Report: Regulatory Framework for Supplements Lacking Necessary Safeguards (Regulatory Focus)
• FDA Grant to Support Neglected Orphan Disease Trials (Regulatory Focus)
• Could Internet Be Path To Simplifying Participation In REMS? (The Pink Sheet)
• HHS: Health law has saved seniors nearly $4B on medications (The Hill)
• FDA Figure is Under Fire (WSJ)
• Introducing the Global Dossier Initiative (USPTO)
• When employee monitoring goes too far (The Federal Times)
• FDA: More scrutiny for surveilled scientist over blocked mammogram devices (Mass Device)
• Negative Headlines Drowning Out FDA's Core Accomplishments (The Pink Sheet)
• A Smarter Approach to Regulation (The White House)

Legislative Update

• Bill Looks to Establish Provisional Approval Framework for Some Products (Regulatory Focus)
• FDA Could Soon Have Better Information to Plan for Massive Budget Cuts (Regulatory Focus)
• New Bill Would Expand Access to Investigational Drugs and Devices (Regulatory Focus)
• Clinical Trial Results to be made Public Under Proposed Legislation (Regulatory Focus)

The Courts

• Pfizer Settles With SEC Over Charges it Bribed Foreign Regulatory Officials (Regulatory Focus)
• Blaming FDA's Enforcement Discretion, Company Files for Bankruptcy (Regulatory Focus)
• J&J in Risperal Settlement (WSJ)
• Teva Gets Subpoena Over Foreign Bribes Probe (Pharmalot)
• Bodybuilding.com Execs Fined for Selling Steroids (Natural Products Insider)
• Appeals court could uphold gene patents, legal experts say (AMA)
• 510(k) Clearance Standards At Issue In Federal Appeals Court Case (The Gray Sheet)
• Louisiana Attorney General Recovers $38 Million from Drug Companies Charged with Fraud
• Scientists Join Lawsuit Against Financial Disclosure (Pharmalot)

Compliance and Safety Issues

• Corporate Fraud Cases Often Spare Individuals (NYTimes)
• Forest Scolded After Doc Complains To FDA (Pharmalot)
• Ranbaxy Lab may have abandoned sleep disorder generic drug Provigil launch (The Economic Times)
• NOV to Valeant Pharmaceuticals (FDA)
• Enforcement Report - Week of August 8, 2012 (FDA)
• Class 1 Recall: FluoroTrak Spinal Navigation System (FDA)

Workshops & Meetings

• FDA Seeks Industry Nominees for Pediatric Advisory Committee (Regulatory Focus)
• Public Conferences: Compliance Through Quality Systems; Implementing and Advancing Sustainable Global Quality Culture (FDA)
• Public Workshop - Medical Countermeasures (MCM) for a Burn Mass Casualty Incident, September 27-28, 2012 (FDA)
• Protection of Global Heparin Supply Focus of International Meeting (USP)
• Upcoming Workshop: Sharing Clinical Research Data, Oct. 4-5 (IOM)
• Public Workshop - Division of Cardiovascular (DCD) 30-Day Notices and Annual Reports Workshop, August 28, 2012 (FDA)

Deals, Acquisitions and Business

• FTC Approves Final Order Settling Charges that Johnson & Johnson's Proposed Acquisition of Synthes, Inc. was Anticompetitive in Market for Treating Traumatic Wrist Injuries (FTC)

EU News

Regulation and Guidance

• COPD Guideline Released by EMA (Regulatory Focus)
• Draft guideline on the use of the CTD format in the preparation of a registration application for traditional herbal medicinal products (EMA)

EMA Information

• EMA to Publish Scientific Opinions on Medicines Contained in Medical Devices (Regulatory Focus)
• EU Science Agency Calls for Experts, Information on Host of Medical Device Safety Issues (Regulatory Focus)

Other EU News

• Manufacturer Seeks to Avoid MHRA Regulation by Registering as Confectionary (Regulatory Focus)
• UK NICE Gives Green Light to Servier's Procoralan for Chronic Heart Failure (Regulatory Focus)
• Opposition mounting to EU's API import regulations (InPharm)
• UK drug pricing negotiations will begin next month (PM Live)
• U.K. Value-Based Pricing Negotiations Could Help NICE-Rejected Cancer Drugs (The Pink Sheet)
• NHS trusts unlawfully denying patients NICE drugs (PharmaTimes)

Global Regulatory News

• Australia: Regulatory Transparency Measures Lead to False Alarms (Regulatory Focus)
• Australia: The TGA decision to ban DMAA (TGA)
• AHWP: Guidance on Mapping of STED to CCSDT (AHWP)
• Australia: Business rules for reduced assessment fees for IVDs (TGA)
• China Rule Puts Primary Responsibility for Excipient Quality on Drug Manufacturers (Regulatory Focus)
• China: China detains almost 2,000 in fake drug sweep (Reuters)
• Indian Regulators Release Draft Clinical Trial Rules (Regulatory Focus)
• Syrian Fighting Leaves Regulatory Wreckage (Regulatory Focus)
• Taiwan: Taiwan's FDA warns of fake medical equipment (Fierce Medical Devices)

Important Studies, Whitepapers and Research

• Research on Pain Medicines Seeks a Genetic-Trait Link (WSJ)
• Newer antidepressants equally effective in treating major depressive disorder (AHRQ)
• Dog Drug Research Threatened (The Scientist)
• Kerfuffle Over Antishock Drug Paper (The Scientist)
• A matter of life and death: The economics of antibiotic resistance (The Milken Institute)

Regulatory Reads

• An Agency 'Warning Letter' Does Not a Lawsuit Make (Corporate Counsel)
• FDASIA, Part 3: Generating Antibiotic Incentives Now (GAIN) and Drug Approval and Patient Access Changes (Ask CATO)
• Regulation and Compliance Q&A: Preparing for Inspections (PharmTech)
• FDA misconduct not deemed newsworthy (Medical Device Daily)
• Getting Drug Research Really, Really Wrong (In The Pipeline)
• Drug Pipeline 'Crisis' a Ploy, Docs Say (Med Page Today)

Other News and Interesting Reads

• Big Med, by Atul Gawande (The New Yorker)