Regulatory Focus: Week in Review (13-17 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

• New 510(k) Guidance Consolidates Pre-Review Policies (Regulatory Focus)
• FDA Calls for Evaluation of Suicidal Ideas and Behavior in all CNS Drug Trials (Regulatory Focus)
• FDA Wants New Study Data Exchange Format (Regulatory Focus)
• Report: Track and Trace Negotiations Resume in Congress (Regulatory Focus)
• EMA Releases EU-Wide Pharmacovigilance Monitoring Plan (Regulatory Focus)
• GHTF Releases Adverse Event Report Standard for Pre-Clinical Trials (Regulatory Focus)
• UK Revamps Drug Regulations (Regulatory Focus)

Regulatory Focus Features

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

US News

• New 510(k) Guidance Consolidates Pre-Review Policies (Regulatory Focus)
• Device Provides Patients, Caregivers with Verbal Instructions for Use (Regulatory Focus)
• CDRH Freedom Of Information Director Aims To Tackle Backlog (The Gray Sheet)
• Wireless device gets privacy OK (Modern Healthcare)

• FDA Calls for Evaluation of Suicidal Ideas and Behavior in all CNS Drug Trials (Regulatory Focus)
• Orphan Drug Marketing Exclusivity Revoked from Product as FDA Admits Error (Regulatory Focus)
• FDA Grants Accelerated Approval to Leukemia Drug (Regulatory Focus)
• Genetic Predisposition to Codeine Overdose Potentially Fatal to Children, Warns FDA (Regulatory Focus)
• Toxicology Program to Assess Chemotherapy Products Used During Pregnancy (Regulatory Focus)
• FDA and EMA set out efforts to mitigate GMP-related shortages (In-Pharma Technologist)
• FDA Asked for More Details on Nano Technology (Med Page Today)
• Big Pharma pilots single-page drug info sheet (MM&M)
• Dissolution Testing Flunks FDA Advisory Committee Exam As Development Tool (The Pink Sheet)
• U.S. FDA widens use of Roche eye drug for diabetics (Reuters)
• Obesity Drug Approval Needs A New Paradigm, Stakeholder Group Says (The Pink Sheet Daily)
• FDA approves vaccines for the 2012-2013 influenza season (FDA)

• FDA Wants New Study Data Exchange Format (Regulatory Focus)
• FTC: Cash isn't required to qualify as pay-for-delay (FiercePharma)
• Comparison of Fourth-Quarter 2011 Average Sales Prices and Average Manufacturer Prices: Impact on Medicare Reimbursement for Second Quarter 2012 (OIG)
• Soaring Ointment Prices Are a Dermatologic Mystery (NYTimes)
• DEA Announces Approved Certification Processes for Electronic Prescriptions (FDA Law Blog)
• FTC Tells Consumers They May Be Due a Refund If They Purchased Disney- or Marvel Hero-themed Children's Vitamins (FTC)

• Senators Call on FDA to Strengthen Antibiotic Monitoring (Regulatory Focus)
• Report: Track and Trace Negotiations Resume in Congress (Regulatory Focus)
• Proposed Legislation Seeks to Avoid Duplicative Trials (Regulatory Focus)
• Bill Would Introduce Greater Transparency, Spending Restrictions on FDA Conferences (Regulatory Focus)

• Watson Files Suit Against FDA over 180-Day Exclusivity (Regulatory Focus)
• Johnson & Johnson still on the hook in patient injury lawsuit over Cypher stent (Mass Device)
• Roche Worker Sues For Whistleblowing & Firing (Pharmalot)
• Judge suspends Georgia Medicaid policy on Makena (BioCentury)
• Use Patents, Carve-Outs, and Incentives - A New Battle in the Drug-Patent Wars (NEJM)

• FDA Cites Chinese Company for Manufacturing Contaminated Wound Care Products (Regulatory Focus)
• FDA Warning Letter Cites IRB for Data Collection Deficiencies (Regulatory Focus)
• Warning Letter Forms Partial Basis for Corporate Takeover Attempt (Regulatory Focus)
• FDA tells drugmaker quality can't be added after production (Fierce Pharma Manufacturing)
• Warning and NOV Letter Summary - 2nd Quarter 2012 (Eye on FDA)
• J&J Executive Named in U.S. Recall Complaint Leaves McNeil Unit (WSJ)

• FDA Announces Series of Workshops Looking at Clinical Trial Design (Regulatory Focus)
• Meetings: Gastrointestinal Drugs Advisory Committee (FDA)
• Meetings: Endocrinologic and Metabolic Drugs Advisory Committee (FDA)
• Division of Cardiovascular Devices 30-Day Notices and Annual Reports; Public Workshop (FDA)
• Workshop to Address Performance, Functionality of Excipients Used in Pharmaceuticals and Foods (USP)

• FTC Seeks Public Comments on Proposed Amendments to the Premerger Notification Rules Related to the Transfer of Exclusive Patent Rights in the Pharmaceutical Industry (FTC)

EU News

• EMA Releases EU-Wide Pharmacovigilance Monitoring Plan (Regulatory Focus)
• EMA Releases Guideline on Conducting Clinical Trials for Atrial Fibrillation Products (Regulatory Focus)
• Draft guideline on the use of the Common Technical Document format in the preparation of a registration application for traditional herbal medicinal products (EMA)

• Workshop on clinical trial data and transparency (EMA)

• UK Revamps Drug Regulations (Regulatory Focus)
• UK Convenes Expert Panel to Assess New Regulatory Framework for Implants (Regulatory Focus)
• Complicated Math Decides UK Patient Access to New Drugs (Regulatory Focus)
• Draft Recommendation by NICE Offers Split Decision on Bone Healing Device (Regulatory Focus)
• NHS chief warns over NICE drug blacklists (Pharma Times)
• ABPI - Guidelines for phase 1 clinical trials (2012 edition) (ABPI)
• UK: Genus reprimanded for 'sexual and titillating' advert (InPharm)

Global Regulatory News

• Australia: OTC cough and cold medicines for children - Final outcomes of TGA review (TGA)
• Brazil: New Drug and Device Import Rules Issued (Regulatory Focus)
• China Finalizes Guidance Approving Counterfeit Manufacturer 'Black Lists' (Regulatory Focus)
• Canada Updates Medical Device Compliance Guidance (Regulatory Focus)
• Canada: Notice - Health Products and Food Branch (HPFB) International Regulatory Forum 2012 (Health Canada)
• GHTF Releases Adverse Event Report Standard for Pre-Clinical Trials (Regulatory Focus)
• Nigeria: NAFDAC considers life in jail for fake drug dealers (Securing Pharma)
• Taiwanese FDA warns of fake medical devices (Securing Pharma)
• WHO position paper on hepatitis a vaccines - June 2012 (WHO)

Important Studies, Whitepapers and Research

• Conflict of Interest Reporting by Authors Involved in Promotion of Off-Label Drug Use: An Analysis of Journal Disclosures (PLoS)
• More trial, less error - An effort to improve scientific studies (Reuters)
• Grapefruit juice may help anti-cancer drugs to be more effective, say researchers (Nutra-Ingredients)

Regulatory Reads

• PwC to U.S. med-device industry: Be prepared (Cardiovascular Business)
• Drug safety: reporting systems for the general public (BMJ)

Other News and Interesting Reads

• OECD Health Data 2012: US (OECD)
• Free Birth Control? Depends on the Brand. (Slate)
• A Giant Hospital Chain Is Blazing a Profit Trail (The New York Times)
• The black (egg) market? IVF recruiters are forgetting about the ethics (Med City News)