Regulatory Focus: Week in Review (11-15 June)

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: [4-8 June][21-25 May] [14-18 May] [7-11 May] [1-4 May] [23-27 April]

Top News Items

DHHS Looks to Reduce Dependence on Animals in Preclinical Testing
The US Department of Health and Human Services (DHHS) is looking ahead to assess the needs of its toxicology program, which it says is a key driver in the adoption of regulatory science-based technologies.

New Patent Rules Could Make China Compulsory Licenser to the World
Following closely in the footsteps of India, China has announced the release of a new patent system in which it can grant compulsory licenses to generic pharmaceutical manufacturers to allow them to make copies of on-patent branded medicines.

FDA Announces Planned Update to Electronic Common Technical Document
The US Food and Drug Administration (FDA) announced its intent to hold a meeting to update stakeholders on the changes it plans to make to Module 1 of the Electronic Common Technical Document (eCTD), which is used to describe administrative and prescribing information for medicines.

Panel Starts Investigation of India's Drug Regulatory Authority
India's regulatory authority, the Central Drugs Standard Control Organization, has not had a particularly good start to 2012. Accounts of corruption and incompetence have been echoed in numerous reports, and now a panel of experts is set to dig further into the agency in the hopes of recommending needed reforms.

Regulatory Focus Features

• Pitfalls in Good Clinical Practice (Regulatory Focus) (Subscription)

US News

Medical Devices

• FDA Staff Expresses Caution Regarding Approval of Edwards' Sapien Heart Valve (Regulatory Focus)
• J&J Warns Physicians About Counterfeit Medical Device (Regulatory Focus)
• St. Jude's Durata Linked to Case of Externalized Wire (Bloomberg)
• Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications (FDA)
• FDA Panel Backs Wider Use of Sapien Valve (Med Page Today)
• Live Blog: FDA Advisory Panel For Edwards Sapien Transcatheter Heart Valve (Forbes)
• Washington Roundup: OIG eyes manager training, but Duval cites reviewers (Medical Device Daily)
• Memorandum Report:  Coverage and Payment for Genetic Laboratory Tests (OIG)
• FDA's Shuren: "The canary in the coal mine is actually singing these days" (Mass Device)
• Open source coding could make medical devices safer (Fierce Medical Devices)
• Women in Medtech: FDA Commissioner Margaret Hamburg (MDDI)
• Device Evaluation Office Seeks Improvement Through CAPA (The Gray Sheet)
• Noisy hospitals need Rx for quiet as patients rest (The Boston Herald)

Pharmaceutical and Biologics

• FDA Announces Planned Update to Electronic Common Technical Document (Regulatory Focus)
• FDA Plans Major Overhaul of Recall Reporting (Regulatory Focus)
• FDA Releases Adverse Event Guidance for Small Businesses (Regulatory Focus)
• FDA Moves to Reduce Backlog of ANDAs (Regulatory Focus)
• Blood Product Guidance Amended to Reflect New Disease Transmission Risks (Regulatory Focus)
• Insurer Moves to Implement Prescribing Limits for Painkillers (Regulatory Focus)
• FDA Gets Permanent Director for Reorganized Surveillance 'Super Office' (Regulatory Focus)
• NIH Drug Development Acceleration Program Expands to Include New Members (Regulatory Focus)
• FDA Approves New Breast Cancer Drug Despite Manufacturing Concerns (Regulatory Focus)
• FDA Extends Review of Gilead Sciences' Controversial HIV PrEP Drug Truvada (Regulatory Focus)
• Reports: Johnson & Johnson to Pay $2.2 Billion to Settle Risperdal Marketing Probe (Regulatory Focus)
• FDA Looks to Reassess Hydrocodone Products (Regulatory Focus)
• Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence Recommendations (FDA)
• Merck Sleep Drug Hits Trial Goals, Raising Hopes for New Blockbuster (Xconomy)
• Janet Woodcock Releases "Director's Mailbag" Q&A Page (FDA)
• Federal Agencies Highlight the Good, Bad And Ugly of Prescription Drug Epidemic (Pain Medicine News)

Other US News

• Government Looks to Regulatory Science to Reduce Dependence on Animals in Preclinical Testing (Regulatory Focus)
• NIH Wants to Educate Children About Clinical Trials Using Video Games (Regulatory Focus)
• Federal Agencies Team Up to Issue Draft Guidance on IRB Transfers (Regulatory Focus)
• PDUFA's 'Huge' GMP Change Will Tie Adulteration To Quality System (The Pink Sheet)
• FDA Starts Initiative to Verify Facility Information (FDA)
• Privacy and Security of Information Stored on Mobile Communications Devices (FTC)
• Reagan-Udall finally receives FDA funding (BioCentury)
• Slides from the May 30-31, 2012 Chronic Pain Workshop (FDA)
• Lilly app aims to boost trial recruitmen (InPharm)
• FDA Inaugurates Annual Patient Network Meeting (FDA)
• Docket Comments: Modernizing the Regulation of Clinical Trials and Approaches to Good Clinical Practice; Public Hearing (FDA)

Legislative Update

• Senator: FDA Stonewalling Investigation into Secret Monitoring (Regulatory Focus)
• Lawmakers: Reform 'Indefensible' Blood Donation Policy (Regulatory Focus)
• Legislators: To Help Alleviate Drug Shortages, Establish Track and Trace Provisions (Regulatory Focus)
• House votes to kill Obama's medical device tax (Reuters)
• Obama Trade Document Leaked (Huffington Post)
• GOP Rep. Ellmers asks administration for plan on health IT safety (The Hill)
• House Panel Approves Bill To Keep FDA Funding Flat (Food Safety News)
• The Arguments for Unit-Level Track and Trace (The RPM Report)
• California Track-and-Trace Law Is Good Model, EMD Serono Says (The Pink Sheet Daily)
• A Battle Over REMS & Samples For Generics (Pharmalot)

The Courts

• Researcher: Regulations Banning Gifts Unlikely to Pass Constitutional Muster (Regulatory Focus)
• Supreme Court Prepares to Hear Amgen's Challenge to Securities Fraud Lawsuit (Regulatory Focus)
• CVS, Rite Aid sue Pfizer over depression drug (Reuters)
• Medicare Drug Discounts At Risk If Court Strikes Health Law (Kaiser Health News)
• Court Rejects FTC's Effort to Require Two Studies (FDA Law Blog)
• AstraZeneca Settles Toprol XL® Class Action Suit (FDA lawyers Blog)

Compliance and Safety Issues

• Warning Letter Analysis: Device Companies Hit for Marketing, Social Media Problems (Regulatory Focus)
• Warning Letter Analysis: Institutional Review Boards Cited for Deficiencies (Regulatory Focus)
• Warning Letter Analysis: Supplement Manufacturers Cited for CGMP Violations, Lawncare (Regulatory Focus)
• Cordis issues "urgent" recall on Fire Star Rx balloon catheters (Mass Device)
• Class 1 Recall: Sigma Spectrum Infusion Pump (FDA)
• Contraceptive pill, ring tied to higher stroke risk (Reuters)
• U.S. Marshals seized misbranded drugs in Maine (FDA)

Deals and Acquisitions

• Pfizer to spin off animal health unit as Zoetis (PMLiVE)
• CHTP cuts executive pay 25 percent, suspends bonuses to pay for trials (MedCity)
• FTC Puts Conditions on Johnson & Johnson's Proposed Acquisition of Synthes, Inc. (FTC)

EU News

Regulation and Guidance

• Concept paper on the need for revision of the note for guidance on the evaluation of the pharmacokinetics of medicinal products in patients with impaired renal function (EMA)
• Concept paper on the need for revision of the note for guidance on the evaluation of the pharmacokinetics of medicinal products in patients with impaired renal function (EMA)
• EMA Wants Harmonized Guideline for IBS Medications (Regulatory Focus)
• EMA Switches to Electronic Submission for Plasma Product Applications (Regulatory Focus)
• European Regulators Want New Gout Guidelines (Regulatory Focus)

EMA Information

• European Regulator Cancels, Postpones Meetings in Face of Traffic
(Regulatory Focus)
• European Medicines Agency welcomes 1000th orphan designation (EMA)

Other EU News

• EU: IMI: 215M euros to tackle major research challenges (Pharma Times)
• Greece: Greek debt crisis: chronic drug shortage risking lives of the sick (The Guardian)
• UK: Denying drugs on age grounds to be illegal: govt (Pharma Times)
• UK: NICE Unveils Mobile Prescribing App to Keep Healthcare Professionals Up-to-date (Regulatory Focus)
• UK: NICE Revises Guidance on Amgen's Denosumab (Regulatory Focus)

Global Regulatory News

• Australia Proposes Changes to How Sponsors Amend Approved Prescription Applications (Regulatory Focus)
• Brazil: Meeting to Discuss New Criteria for Therapeutic Indications (Regulatory Focus)
• Brazil: Anvisa Publishes New GMP Inspection Guide (Regulatory Focus)
• China: Milestone Meeting Held Between Chinese, Taiwanese Regulators (Regulatory Focus)
• China: SFDA Issues New Draft Excipient Rules (Regulatory Focus)
• China: New Chinese Patent Rules Could Make Country Compulsory Licenser to the World (Regulatory Focus)
• India: Panel Starts Investigation of India's Drug Regulatory Authority (Regulatory Focus)
• India: As Regulatory Problems Accumulate In India, Clinical Trials Sector Looks to Flee (Regulatory Focus)
• India: India stresses on importance of collaboration with US in food and drug regulation (The Economic Times)
• India: Indian pharma companies like Ranbaxy, Dr Reddy's & others eye $1bn generic opportunity (The Economic Times)
• India: Indian SMEs need Gov support to comply with GMPs; report (In-Pharma Technologist)

Important Studies, Whitepapers and Research

• NIH Human Microbiome Project defines normal bacterial makeup of the body (NIH)
• JAMA: Time to rethink aspirin's CV benefits (Cardiovascular Business)
• Computer model successfully predicts drug side effects (EurekAlert)

Regulatory Reads

• Regulators Not Ready To Get Behind Most "Pragmatic Trials" Before Approval
• Charting a Path to Personalized Medicine: Regulatory Challenges Loom for Companion Diagnostics (BioWorld)
• What It Really Takes to Change Washington (The Atlantic)
• Regulation of Personalized Medicine: A Status Report (Pharma Manufacturing)
• The Cost of Quality Failures (PharmTech Talk)
• PET Drugs - Time to file that NDA, ANDA or IND (CATO)
• Playing Fair with Industry (The Scientist)
• Advertising masked as science? (Nature)
• A better type of clinical trial? (LA Times)
• Protecting Clinical Trial Participants and Protecting Data Integrity: Are We Meeting the Challenges? (PLoS)
• Clinical Trials Have Gone Global: Is This a Good Thing? (PLoS)
• Surge in products being recalled may be numbing consumers (USA Today)
• While healthcare apps are on the rise, the FDA threatens to stifle innovation in the U.S. (The Next Web)
• Warning: Your "Check CAPA" Light is On (CATO)
• Are you ready for the new EU pharmacovigilance legislation changes? Part 1 (PharmaPhorum)
• A Step Behind Globalization (Drug Discovery and Development)

Other News and Interesting Reads

• Manipulating Eggs to Avoid Disease (The Scientist)
• American Pain: The Largest U.S. Pill Mill's Rise and Fall (Business Week)
• The App as Health Aide (The New York Times)