Regulatory Focus: Week in Review (18-22 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: [11-15 June] [4-8 June][21-25 May] [14-18 May] [7-11 May] [1-4 May]
Top News Items
FDA User Fee Bill Easily Passes the House, On Pace for July Approval
The Food and Drug Administration Safety and Innovation Act (FDASIA) is set for a vote in the Senate next week after receiving overwhelming approval from the US House of Representatives on 20 June. The user fee legislation would reauthorize and modify a number of existing programs that provide industry funding for activities at the US Food and Drug Administration (FDA) and make a litany of changes at the agency. More »
EMA Releases Final Biosimilar Guidelines
The European Medicines Agency (EMA) has finalized two guidance documents pertaining to medicines containing monoclonal antibodies. The two guidance documents address two different aspects of the development of biosimilar medicines: in vivo clinical testing of medicinal products and aspects related to nonclinical and clinical testing. More »
Researchers: FDA Beats EMA, Health Canada in Drug Approval Times
A recent study published in the New England Journal of Medicine (NEJM) stated that the US Food and Drug Administration (FDA) approved drug products nearly two months faster than its European and Canadian counterparts on average and got products to market first in the majority of cases. After including the total review time in their analysis, investigators said their research "found more proof that the FDA is faster than its peers." More »
MHRA Warns of Counterfeit Medical Devices
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) sent out a warning to physicians and consumers recently regarding the discovery and seizure of several counterfeit medical devices sold through online retailers. The agency said it had seized hundreds of discount-priced devices lacking proper CE safety marking, warnings or instructions for proper use. More »
Regulatory Focus Features
- It's a Small World: Collaboration and Harmonization in an Ever-shrinking World (Regulatory Focus) (Subscription)
- Pythons-A Model to Study Human Heart Disease? (Regulatory Focus) (Subscription)
- Pitfalls in Good Clinical Practice (Regulatory Focus) (Subscription)
- A Conversation With FDA's Human Factors and Accessible Medical Technology Expert (Regulatory Focus)
US News
Medical Devices
- CDRH Science Office's Annual Report Highlights New Initiatives (Regulatory Focus)
- New Draft Guidance Establishes Special Controls for Blood Access Devices (Regulatory Focus)
- Path opens up for FDA regulation of mobile medical apps(Healthcare Finance News)
- CareFusion respiratory programs "riddled" with malware (Mass Device)
- Dialing Back on Radiation in CT Scans to Lower Risk (WSJ)
- FDA investigates Fresenius over kidney dialysis controversy (Fierce Medical Devices)
- FDA clears St. Jude's vascular plug (Cardiovascular Business)
- Compliance Takes Back Seat to Quality at CDRH (MDDI)
- FDA Plans Fall Launch Of Device Adverse Event Smartphone App (The Gray Sheet)
Pharmaceutical and Biologics
- Disease-information Enhanced Advertisements May Be Misleading Consumers, Says FDA (Regulatory Focus)
- Researchers: FDA Beats EMA, Health Canada in Drug Approval Times (Regulatory Focus)
- FDA Wants Supply Chain Security Pilot Program to Continue (Regulatory Focus)
- FDA Releases Draft Guidance for Veterinary Trials (Regulatory Focus)
- Former FDA Commissioner Calls for Agency Reforms (Regulatory Focus)
- Government Report Blames Drug Shortages on FDA, Calls for Change in Warning Letter Policy (Regulatory Focus)
- FDA Maintains Compounding Exemption for KV Pharmaceuticals' Makena (Regulatory Focus)
- Study: FDA's Risk Communications and Warnings Not as Effective as Hoped (Regulatory Focus)
- FDA Looks to Support Animal Rule With New GLP Training Program (Regulatory Focus)
- New Combination Vaccine Approved by FDA (Regulatory Focus)
- Town Hall: FDA Braces for PDUFA V, Possible Loss of Biosimilars Authority (Pharma Manufacturing)
- FDA's Benefit/Risk Framework Will Focus On Communication, Not Quantification (The Pink Sheet Daily)
- FDA drug review proposal draws critics at BIO Convention (The Boston Globe)
- FDA advisers back Onyx blood cancer drug (Reuters)
- FDA holds up Pfizer's rare disease drug tafamidis (InPharm)
- US paediatric Rx drug use fell 7% during 2002-2010: FDA (Pharma Times)
- FDA Panel Nixes Semuloparin (Med Page Today)
- Blood Substitutes: Working to Fulfill a Dream (FDA)
- AMA may urge requirement of early warning of drug shortages (Philly Pharma)
- Report: Pregnancy line was struck from guide to 'morning-after pill' (The Hill)
Other US News
- Agency Takes Aim at FDA in Whistleblowing Guidance (Regulatory Focus)
- Group Nominates More Than 60 Scientists to Fill Advisory Committee Vacancies (Regulatory Focus)
- Reports: FDA to Overhaul New Dietary Ingredient Guidance (Regulatory Focus)
- Study Calls for Additional Regulation of Package Labeling (Regulatory Focus)
- Agency Looks to Overhaul Voluntary Fraud Reporting Program (Regulatory Focus)
- FDA proposal gives pharmacists too much power, doctors argue (Fox News)
- Pfizer Ends Social Media Bid For Trial Recruitment (Pharmalot)
- Will the GSA Be Able to Break Free of the DUNS Number? (POGO)
- Obama boosts bioterrorism defenses (The Hill)
- PCORI Announces Pilot Projects Program Awards Recipients, Research Topics (PCORI)
- War on drugs moves to pharmacy from jungle (Reuters)
Legislative Update
- FDA User Fee Bill Easily Passes the House, On Pace for July Approval (Regulatory Focus)
- Report: Track and Trace Provisions Removed from User Fee Bill (Regulatory Focus)
- House to Vote Wednesday on FDA User Fee Legislation (Regulatory Focus)
- Congress Releases Final Version of User Fee Bill, Shedding Controversial Provisions (Regulatory Focus)
- House Passes Bill Enhancing Penalties for Counterfeiters (Regulatory Focus)
- H.R. 3668, Counterfeit Drug Penalty Enhancement Act of 2012 (Congressional Budget Office)
- H.R. 4223, SAFE DOSES Act (Congressional Budget Office)
- H.R. 5973 - Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2013 (House Committee on Rules)
- FDA Panel Conflict Rules Loosened By PDUFA (Pharmalot)
- Widespread praise for drug bill (Nature)
- GOP on Health Care: No Quick Replacement (AP)
The Courts
- J&J close to settling with DOJ over marketing: WSJ (WSJ)
- Drug reps ineligible for overtime pay, court says (Modern Healthcare)
- Vaccine Autism Liability Cases Disappearing, DoJ Reports (The Pink Sheet Daily)
- Ark. judge says no new trial in J&J Risperdal case (PharmPro)
- New Study Examines Citizen Petitions; Concludes that Petitions are on the Rise and that 505(q) Has Been Unsuccessful (FDA Law Blog)
- Alarm sounded on copycat drugs regulation (Financial Times)
- Merck: Court rejected its claim over allergy drug (PharmPro)
Compliance and Safety Issues
- Warning Letter Analysis: Siemens, Terumo Cited for Adulterated Devices (Regulatory Focus)
- Revised FDA Enforcement Report Stresses Clarity, Data Accessibility (Regulatory Focus)
- Group to FTC: Merck's Marketing Tie-ins Violate Advertising Regulations (Regulatory Focus)
- Insight: Top heart doctors fret over new blood thinners (Reuters)
- Ranbaxy Runs Afoul Of Regulators, Again (Pharmalot)
- Kidney-donor deaths linked to surgical clips raise issues of alerts, warnings (CNN)
- Nidek Medical Products, Inc. issues an Urgent Medical Device Correction affecting
- oxygen concentrators (FDA)
- SIGMA Spectrum Infusion Pump Model 35700 - Expanded Recall (FDA)
- Class 1 Recall of GE's Aestriva Smart Vent (FDA)
Workshops & Meetings
- Gastrointestinal Drugs Advisory Committee (FDA)
- Dermatologic and Ophthalmic Drugs Advisory Committee (FDA)
- 2012 Meeting Materials of the General and Plastic Surgery Advisory Panel (FDA)
Deals, Acquisitions and Business
- Bugs living in humans breed biotech startups (Fierce Biotech)
- AstraZeneca completes $1.26B Ardea purchase (PharmPro)
- How To Kill A Drug Company: Reorganize The Life Out Of It (Forbes)
EU News
Regulation and Guidance
- EMA Releases Final Biosimilar Guidelines (Regulatory Focus)
- European Commission: Non-EU Reference Product OK for EU Biosimilars (Regulatory Focus)
- European Commission Opens Review of Variations Guidance (Regulatory Focus)
EMA Information
- European Commission Proposes User Fees to Support Pharmacovigilance Program (Regulatory Focus)
- European Legislators Propose Premarket Approval System for Some Medical Devices (Regulatory Focus)
- European Medicines Agency website on suspected side effect reports now in all 23 EU official languages (EMA)
- Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24 May 2012 (EMA)
- Quality of medicines questions and answers: Part 1 (EMA)
- Quality of medicines questions and answers: Part 2 (EMA)
Other EU News
- UK: Investigation Clears Faulty Implants of Most Serious Safety Concerns (Regulatory Focus)
- UK: MHRA Warns of Counterfeit Medical Devices (Regulatory Focus)
- UK: NICE Determines Cost Trumps Benefit For New Melanoma Drug (Regulatory Focus)
- UK: Drug shortages: DH "must provide leadership" (Pharma Times)
Global Regulatory News
- Australia: Update on TGA decision to cancel prescription pain-killers (TGA)
- China: Toxic capsules help the medicine go down in China (Reuters)
- Brazil: Regulation Seen as Supporting Social And Economic Development (Regulatory Focus)
- Brazil: Risk Management Plans Shouldn't Prevent Drug Access for Generic Companies (Regulatory Focus)
- India: CDSCO launches 'similar biologics' guidelines at BIO2012 (In-Pharma Technologist)
- India: Smaller Indian drugmakers need support to improve GMPs (Fierce Pharma Manufacturing)
Important Studies, Whitepapers and Research
- Researchers: Have Clinical Trial Regulation Progressed too Quickly in Developing Nations? (Regulatory Focus)
- 10,000 Germ Species Live In And On Healthy People (NIH)
- BMJ: diabetes post-marketing studies used to boost sales (InPharm)
- Doctors Ditching Pharma Due To Increased Scrutiny (Medical News Today)
- Walking the Global Tightrope: Balancing the Risks and Rewards of Med-Tech Globalization (PWC)
- Physicians are biased when evaluating medical conflict of interest policies (EurekAlert)
- E&Y: Biotech looks stable, but warning signs cloud the future (Fierce Biotech)
Regulatory Reads
- The Regulatory Future of mHealth: FCC, FDA and the United States Congress (JD Supra)
- The Real Promise of Mobile Health Apps (Scientific American)
- Match.coms of clinical trials make it easier to connect patients, researchers (Med City News)
- Do Pharmaceutical Salespeople Sometimes Make Patients Safer? (Forbes)
- FDA's Voluntary Audit Program and the Hangman's Paradox (MDDI Online)
- How to leverage the NCATs template across the industry (Medical Progress Today)
- Rare diseases expert: Marketable orphan drugs will soon require diagnostic+therapy (Med City News)
- Disease-Mongering of Low Testosterone (Med Page Today)
- Seven Success Criteria for Hiring (and working with) a Good GMP Consultant (FDAzilla)
- The Latest on Mercury-Based Dental Amalgam-The Other HHS Stall at FDA (MDDI)
- More On Why The Adverse Event Reports On Gardasil Don't Point To A Problem (Forbes)
- Economist, why so pessimistic about open source medical devices software? (Medical Devices Legal)
- Changing the FDA's Culture (National Affairs)