Regulatory Focus: Week in Review (16-20 July)
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: [9-13 July] [18-22 June] [11-15 June] [4-8 June][21-25 May] [14-18 May]
Top News Items
- Investigation into FDA Reveals 'Enemies List,' Extensive Monitoring Practices (Regulatory Focus)
- New EU Clinical Trials Proposal to Ease Pharmaceutical Industry's Concerns (Regulatory Focus)
- Report: EMA to Make Public All Clinical Trials Data (Regulatory Focus)
- Pressure Mounts on FDA Over Surveillance Scandal (Regulatory Focus)
- Major Regulatory Changes Proposed in House Bill (Regulatory Focus)
- House Budget Draft Eliminates Comparative Effectiveness Research Agencies (Regulatory Focus)
- FDA Approves Landmark HIV Prevention Pill (Regulatory Focus)
- FDA Approves Vivus' Obesity Weight Loss Drug Qsymia (Regulatory Focus)
- Court: 'Pay-for-Delay' Practice Anticompetitive, Illegal (Regulatory Focus)
Regulatory Focus Features
[Have you read any Regulatory Focus feature articles yet? For July only, they're free to view without a subscription!]
- How Safe Are Biosimilars? Implications of FDA and EMA Guidances and European Experience since 2006-Part 2 (Regulatory Focus)
- Lister and Semmelweis - Two Misunderstood Geniuses (Regulatory Focus)
- Simplify (Regulatory Focus)
- East Africa Leads Medicine Registration Harmonization Thrust (Regulatory Focus)
- RAPS DC/Baltimore Chapter Sponsors Career Day at Johns Hopkins (Regulatory Focus)
- Finding the Perfect Match: Mentors Guide Professionals (Regulatory Focus)
US News
Medical Devices- FDA Looks to Establish Patient Registry to Assess Risks of Imaging Contrast Agents (Regulatory Focus)
- Breathe Deeply: A Comeback For Primatene Mist? (Pharmalot)
Pharmaceutical and Biologics
- FDA Approves Landmark HIV Prevention Pill (Regulatory Focus)
- FDA Approves Vivus' Obesity Weight Loss Drug Qsymia (Regulatory Focus)
- Office of Generic Drugs Receives New Director (Regulatory Focus)
- Report: Human Tissue Donation Rules Lack 'Inadequate Safeguards' (Regulatory Focus)
- FDA approves new colon-cleansing drug for colonoscopy prep (FDA)
Other US News
- Investigation into FDA Reveals 'Enemies List,' Extensive Monitoring Practices (Regulatory Focus)
- Pressure Mounts on FDA Over Surveillance Scandal (Regulatory Focus)
- FDA's 'Bad Ad' Program Marks Second Year of Operation (Regulatory Focus)
- OIRA Seeks Ways to Simplify Regulations (Regulatory Focus)
- HHS among agencies meeting cloud computing goals: audit (Modern Healthcare)
- Rise in Pill Abuse Forces New Look at U.S. Drug Fight (NYTimes)
- Quick Look at FDA's Mexico Post and Our Global Work (FDA)
- California county wants drug makers to pay for pill disposal (Reuters)
- Updated: Associations welcome Durbin-Blumenthal cGMP dialogue & FDA explains GMP violation stats (NutraIngredients-USA)
- HHS and EPA Can Improve Practices Under Special Hiring Authorities (GAO)
Legislative Update
- Major Regulatory Changes Proposed in House Bill (Regulatory Focus)
- House Budget Draft Eliminates Comparative Effectiveness Research Agencies (Regulatory Focus)
- Proposed Legislation Would Restrict Access to Common Cough Suppressant (Regulatory Focus)
- Prominent Senator Slams FDA over Surveillance Program (Regulatory Focus)
- Sunshine for Regulatory Decrees and Settlements Act of 2012 (THOMAS)
- House subcommittee approves bill defunding AHRQ (Healthcare IT news)
- Medical device tax: Hatch's bid to attach repeal to small business tax bill falls short in Senate (Mass Device)
- Patient advocates, drugmakers fight 'fail-first' policies (California Watch)
The Courts
- Court: 'Pay-for-Delay' Practice Anticompetitive, Illegal (Regulatory Focus)
- Reports: J&J Reaches Agreement to Settle Lawsuit Over 'Tsunami of Regulatory' Problems (Regulatory Focus)
- J&J Escapes Class Action Suit Over Recalls (Pharmalot)
- Court: Doctors, not drugmakers, must warn patients of risks (AMA)
Compliance and Safety Issues
- Untitled Letter Cites BMS for Alleged Misbranding (Regulatory Focus)
- J&J ramping up OTC production as 'decree' work allows (Fierce Pharma)
- FDA seeks to halt production, distribution of dietary supplements at NY company (FDA)
- Hospira Announces A Nationwide Recall of Certain Lots of Injectable Carboplatin, Cytarabine, Paclitaxel and Methotrexate Due to Glass Vial Defect (FDA)
- Class 1 Recall: EnVe Ventilator (FDA)
- Class 1 Recall: Infusomat(R) Space Pump (FDA)
- Canadian Internet pharmacy leader faces federal charges (Fierce Pharma Manufacturing)
- Enforcement Report - Week of July 18, 2012 (FDA)
- After cGMP no-no's cited, Indian drugmaker says FDA accepts remedies (Fierce Pharma Manufacturing)
Workshops & Meetings
- FDA Plans to Focus on Tablet Scoring, Nanotechnology at Upcoming Meeting (Regulatory Focus)
- Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting (FDA)
- Vaccines and Related Biological Products Advisory Committee; Notice of Meeting (FDA)
- Public Workshops: Use of Influenza Disease Models to Quantitatively Evaluate the Benefits and Risks of Vaccines (FDA)
- Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting (FDA)
- Regulatory Science Considerations for Medical Countermeasure Radiation Biodosimetry Devices (FDA)
- Advisory Committee for Pharmaceutical Science and Clinical Pharmacology (FDA)
- Agency Information Collection Activities; Proposals, Submissions, and Approvals: Guidance for Industry on Formal Meetings With Sponsors and Applicants for Prescription Drug User Fee Act Products (FDA)
Deals, Acquisitions and Business
- GSK clinches deal to buy Human Genome for $3 billion (Reuters)
- Despite Deal With TPG, Speculation That Par Could Garner Higher Bids (The New York Times)
- 'Golden parachute' for AZ's David Brennan (InPharm)
- FTC Puts Conditions on Novartis AG's Acquisition of Fougera Holdings, Inc. (FTC)
EU News
Regulation and Guidance- EMA Opens Consultation on Product Information Changes (Regulatory Focus)
- Final Guideline on Antibiotic Impurities Focuses on Manufacturing Processes (Regulatory Focus)
- EMA Releases Updated Final Guideline on Active Substance Master Files (Regulatory Focus)
EMA Information
- New EU Clinical Trials Proposal to Ease Pharmaceutical Industry's Concerns (Regulatory Focus)
- Report: EMA to Make Public All Clinical Trials Data (Regulatory Focus)
- European Medicines Agency appoints Head of International and European Cooperation (EMA)
- EMA Employee Claims Conflict Rules Are Unfair (Pharmalot)
- European Medicines Agency post-authorisation procedural advice for users of the centralised procedure (EMA)
- European Medicines Agency holds first meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) (EMA)
- Annual report of the Good Clinical Practice Inspectors Working Group 2011 (EMA)
Other EU News
- Continuing Transparency Push, EMA to Make all Meeting Minutes Public (Regulatory Focus)
- European Commission and UK Government Announce Plans to Support Open Access Publishing (MedTechInsider)
- DRAFT REPORT on the Microbial Challenge - Rising threats from Antimicrobial Resistance (European Parliament)
- UK Proposes Reimbursement-based Accelerated Approvals Process (Regulatory Focus)
- UK: NICE to offer early advice to payers about new medicines (PMLiVE)
Global Regulatory News
- Australia: Australian woman wins multi-million Thalidomide payout from Diageo (Reuters)
- Australia: Seminar: Reclassification of hip, knee and shoulder joint replacement implants (TGA)
- Canda: Therapeutic Products Directorate Statistical Report 2011 (Health Canada)
- Canada: Mold may lead to Sanofi cancer drug shortage (Fierce Pharma Manufacturing)
- China: A China Headache for World's Big Pharma Companies (CNBC)
- India: Unique ID for drugs to check fake medicines (The Economic Times)
- India: India postpones deadline for drug export barcoding again (Nick Taylor)
- India: Govt limits MNCs' supply of essential drugs on local buy (Economic Times of India)
- India: Pharmaceutical industry agrees to enforcement of marketing code: Indian Pharmaceutical Alliance (Economic Times of India)
- ISO: Microbe-free cosmetics with new ISO standard (ISO)
- USP: New Publication Helps Compounding Practitioners Ensure the Quality of Customized Preparations Important Studies, Whitepapers and Research (US Pharmacopoeia)
Regulatory Reads
- Study: No Regional Differences in Trial Data Quality (Regulatory Focus)
- Are Meta Tags a Regulatory Time Bomb? (Dose of Digital)
- FDA: Where All The Drugs Are Above Average (The RPM Report)
- The Truth About Drug Shortages (Biopharm International)
- FDA's Mermaid Problem: Makena and Pharmaceutical Half-Breeds (The RPM Report)
- Why you need to pay attention to GSK's corporate integrity agreement with the DOJ (Med City News)
- Are Warnings About the Side Effects of Drugs Making Us Sick? (PLoS Blogs)
- Transgenic Animals In Preclinical Safety Testing (Life Science Leader)
- Dear F.D.A.: Stop Drugging Animals (NYTimes)
Other News and Interesting Reads
- In the Age of Anxiety, are we all mentally ill? (Reuters)
- The biodefender that cries wolf (LATimes)
- A Glimpse of Senate Health Policy Deliberations (Med Page Today)