Regulatory Focus: Week in Review (23-27 April)

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. If you read just one thing this week, make it Regulatory Focus' Week in Review.

Previous Week in Reviews: [16-20 April] [9-13 April] [2-6 April] [26-30 March]

Top News Items

User Fee Act Passes Senate Panel While Tensions Escalate in the House
The US Senate's Health, Education, Labor and Pensions (HELP) Committee passed a collection of user fee acts in a bill called the Food and Drug Administration Safety and Innovation Act (FDASIA), while members of the House of Representatives remained at odds over various aspects of proposed user fee legislation. More »

China Probe Into Chromium-Laced Capsules Escalates
Chinese regulatory authorities have announced the expansion of a probe into pharmaceutical capsules illicitly laced with Chromium, saying they have arrested nine more people, detained a further 45 and seized more than 77 million capsules, reports Reuters. More »

Internal FDA Reports Slams EU Regulation of Medical Devices
The US Food and Drug Administration (FDA) has lambasted Europe's review process for medical devices in an unreleased internal report, claiming the failure of some devices to obtain FDA approval despite being approved in Europe is an "affirmation of the US medical device approval process," reports the Minneapolis Star Tribune. More »

EMA Electronic Submission Gateway Goes Live for Human Medicines
The European Medicines Agency (EMA) is announcing its eSubmission Gateway-the "electronic submission channel" for submitting electronic common technical documents (eCTDs) to EMA-is now up and running for all applicants for centralized marketing authorizations. More »

Regulatory Focus Feature Articles

• Regulatory Environment Changes Affect REMS (Regulatory Focus) (Subscription)
• Bloodletting and Malariatherapy: Treatment Methods of the Past (Regulatory Focus) (Subscription)
• "I'm In Regulatory Affairs. Why would I want business training?" (Regulatory Focus) (Free)
• Outstanding Contributions Deserve Outstanding Recognition (Regulatory Focus) (Free)
• Congratulations to the Autumn 2011 RAC Class (Regulatory Focus) (Free)

US News

• FDA Issues Draft Guidance on Inclusion of Nanomaterials in Cosmetic Products (Regulatory Focus)

FDA Information: Medical Devices

• Report: FDA Developing UDI Barcode System for Medical Devices (Regulatory Focus)
• Report: Internal FDA Reports Slams European Regulation of Medical Devices as Ineffective (Regulatory Focus)
• CDRH Plans To Redraft Maligned 510(k) Modifications Proposal (The Gray Sheet)

• Biosimilars Guidelines Attract Attention, Criticism (Regulatory Focus)
• Industry Comments Indicate Displeasure with Medication Guides, FDA Looking at Single-Page Versions (Regulatory Focus)
• Hamburg: Nanotechnology Regulation Likely to Become 'More Nuanced,' Outlines Regulatory Approach (Regulatory Focus)
• Woodcock: FDA Time, Resources Now Split Equally Between Premarket, Postmarket Analysis (Regulatory Focus)
• Nebraska Raises Stakes in Battle With FDA, Won't Surrender Supply of Controversial Drug (Regulatory Focus)
• FDA Releases Strategic Plan for Veterinary Medicine Program (Regulatory Focus)
• Abbott Asks FDA to Refuse Certain Biosimilar Applications (Patent Docs)

• FDA 'Aghast' at Lack of cGMP, AER Compliance by Supplement Manufacturers (Regulatory Focus)
• FDA Report: Agency Moving to Engage Globally to Meet Realities of Supply Chain (Regulatory Focus)
• Former FDA Commissioner: 'New Paradigm Shift' Means Agency Must Approve Treatments Faster (Regulatory Focus)
• BIO Head Calls for New Position to be Formed at FDA to Boost Innovation (Regulatory Focus)
• FDA Getting New Director of Office of Criminal Investigations (Regulatory Focus)
• Hamburg: 2012 may prove 'a landmark year' for legislation (Medical Device Daily)

• Patient Group Collaborations Continue as Sanofi, Michael J Fox. Foundation Team Up (Regulatory Focus)
• C-Path Initiative's Work on Personalized Medicine Starts to Get Results (Regulatory Focus)
• Novartis Gets Mixed News on MS, HCV Drugs From EMA, FDA (Regulatory Focus)
• Marketers Reach for Wrinkle Cream as Cosmetic Claims Face Scrutiny (Ad Age)
• Generic Industry's Drug Shortage Program Creates Trigger Mechanism For FDA (Pink Sheet Daily)
• ACRO wants faster progress on clinical trial modernisation (Pharma Times)
• Bos Sci now under fire for ICD-related patient death (Cardiovascular Business)

• User Fee Act Passes Senate Panel While Tensions Escalate in the House (Regulatory Focus)
• Report: 'Track and Trace' Anti-Counterfeiting Provisions Likely Casualty of User Fee Markup (Regulatory Focus)
• Report: Fight Over FDA User Bills Threatening To Derail Legislation (Regulatory Focus)
• House PDUFA Draft: Make FDA's Review Process Take Into Account Job Creation (Regulatory Focus)
• CBO Scoring of H.R. 4078, Regulatory Freeze for Jobs Act of 2012 (CBO)
• Markey fails to get movement on new medical device regulations (The Boston Globe)
• Massachusetts Congressman Calls for 510(k) Reform Provisions in User Fee Act (MDDI)
• FDA's Globalization Strategy Needs To Be More Aggressive, Sen. Brown Suggests (The Pink Sheet Daily)
• Senate User Fee Bill Heads To Mark-up Without Track-And-Trace (The Pink Sheet Daily)
• Government shutdown on the horizon? (Politico)
• New reforms in Senate PDUFA bill (BioCentury)
• Drug Shortages Proposal From Sen. Hatch Offers 7-Year Economic Incentives (The Pink Sheet)

• Merck Settles Vioxx Criminal Charges With US for $322 Million (Regulatory Focus)
• Medtronic wins pain pump case on preemption (Mass Device)
• Drugmakers win on appeal in 'pay-for-delay' case (Modern Healthcare)
• Absolutely, Totally, and in All Other Ways Inconceivable? Nope, Says the Federal Circuit in YASMIN Hatch-Waxman Method Patent Litigation (FDA Law Blog)
• New User Fee Design Presents Opportunities to Build on Transparency and Communication Success (GAO)
• In Stem Cell Suit Appeal, Arguments Over Technicalities (Science Magazine)
• Prometheus Rebound: Where Weak Patents Can Benefit Pharma (The RPM Report)

• Annual Food and Drug Administration-Orange County Regulatory Affairs Educational Conference: Sustainable Regulatory Practices, Irvine, CA (FDA)
• Circulatory System Devices Panel of Medical Devices Advisory Committee (FDA)
• Oncologic Drugs Advisory Committee (FDA)
• Assessing the Economics of Genomic Medicine: A Workshop (IOM)
• Health Subcommittee Vote on Legislation to Reauthorize Various FDA User Fee Programs (Congress)
• Studying the Safety of Approved Drugs: IOM Report Releases May 1 (IOM)

• Company Cited for Failure to Follow Numerous Medical Device cGMP Regulations (Regulatory Focus)
• Analysis: FDA Warning Letters in 2011 Mostly Focused on Batch Failures (Regulatory Focus)
• FDA Calls out Pharma Company for Repeated 'Violative' Marketing Practices (Regulatory Focus)
• FDA: Companies Who Dealt With Cetero Must Repeat or Confirm Some Bioanalytical Studies (Regulatory Focus)
• Public Citizen to FDA: Diabetes Drug Unsafe, Should Be Pulled (Regulatory Focus)
• FDA warns 56 more docs of fake Avastin supplies (Fierce Pharma)
• FDA Issues Second Warning to Physicians about Certain Compounded Drugs from Franck's (FDA)
• FDA Drug Safety Communication: New Warning and Contraindication for blood pressure medicines containing aliskiren (Tekturna) (FDA)
• FDA - Fentanyl Patch Can Be Deadly to Children (FDA)
• Two Israeli Men Sentenced for Smuggling Counterfeit and Misbranded Cialis into the United States (FDA)
• FDA cites orthopedic medical device company over violations (Med City News)
• U.S.: do not mix Merck hepatitis pill with HIV drugs (Reuters)
• Recently Posted Warning Letters  (FDA)
• MedWatch Safety Alerts: March 2012 (FDA)

Deals and Acquisitions

• AstraZeneca CEO Out as New J&J CEO Takes the Helm (Regulatory Focus)
• IMS Health Buys DecisionView For Programs to Speed Clinical Trials (Xconomy)
• Human Genome Most Lucrative on Record Biotech Premiums (Businessweek)
• Pfizer, AstraZeneca make deals (Philly Pharma)

EU News

• EMA Launches New Board to Coordinate Committees' Scientific Standards (Regulatory Focus)
• Electronic Submission Gateway Goes Live for Human Medicines Submissions, Announces EMA (Regulatory Focus)
• EMA Publishes Updated Guidance on Premarketing, Postmarketing Procedures (Regulatory Focus)

• Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 April 2012 (EMA)
• European Medicines Agency recommends authorisation of novel treatment for type 2 diabetes (EMA)
• European Medicines Agency maintains recommendation not to grant a marketing authorisation for Glybera (EMA)
• Group: Global framework for biosimilars "is now crucial" (Pharma Times)

• UK: Government to speed up access to new cancer drugs (Regulatory Focus)
• UK: Novartis challenges UK Avastin use in eye disease (Regulatory Focus)
• UK: NICE opens NHS door to MS, CML and Hep C drugs (Pharma Times)
• UK: First Oral Therapy for MS Gets NICE Approval (Regulatory Focus)
• EU: Once a friend now an enemy: Over zealous EU regulators could hamper the CMO market, says analyst (Outsourcing Pharma)

Global Regulatory News

• Australia: Draft Guidance on Evidence to Support Indications for Low Risk Medicines (Regulatory Focus)
• Australia: TGA Calls for Comments on Evidence Needed to Support Low-Risk Claims (Regulatory Focus)
• Brazil: House Holds Hearing on Breast Implants (Regulatory Focus)
• Brazil: Consultation Open on Criteria for Priority Review (Regulatory Focus)
• Brazil: Advisory Council Discusses New ANVISA (Regulatory Focus)
• Canada: Health Canada, Facing Budget Cuts, Lays off Hundreds of Employees (Regulatory Focus)
• China: NIFDC Strategic Advisory Expert Committee and the Eighth Academic Committee established (SFDA)
• China: Healthcare Reform Opportunity To Strengthen Regulation (Regulatory Focus)
• China: Device Testing and Globalization of Trade (Regulatory Focus)
• China Probe Into Chromium-Laced Capsules Escalates, 77M Capsules Seized (Regulatory Focus)
• GHTF Proposes New Harmonization of Medical Device Audits (Regulatory Focus)
• India: Ranbaxy launches first indigenous malaria drug (The Economic Times)
• Ireland: HIQA Releases Economic Evaluation of Repeat Universal Antenatal Screening for HIV in the Third Trimester of Pregnancy (Regulatory Focus)
• ISO: What's in a Frame? ISO Releases New Standard for Glasses Frames (Regulatory Focus)
• Kenya: Kenya set to repeal controversial anti-counterfeit law (Securing Pharma)
• Malaysia: Legislation to establish medical device regulatory framework advances in Malaysia (Regulatory Focus)
• Pakistan: Raw material woes for Pakistan could lead to swift exit for drugsmakers, says ABC (in-Pharma Technologist)
• PIC/S: Korea, Japan Apply for PIC/S Membership (Regulatory Focus)
• Singapore: Singapore streamlines fees, approval times for low-risk devices (Fierce Medical Devices)

Important Studies, Whitepapers and Research

• Report: Phase III Clinical Trials Behind Increase in the Cost of Pharmaceuticals (Regulatory Focus)
• Study: Pediatric Clinical Trials Guilty of Publication Bias, NIH Falling Short of Obligations (Regulatory Focus)
• Meta-Analysis Compares Drug-Eluting and Bare-Metal Stents for Primary Angioplasty (Forbes)
• The Ethics Police?: IRBs' Views Concerning Their Power (PLoS)
• Bioethicists urge less regulation for some human subjects research (The JHU Gazette)
• US IRB's Confronting Research in the Developing World (Developing World Bioethics)
• Device industry reputation is better than pharma's, say patient groups (Pharma Times)
• 40 percent of scientific papers published in the world's top medical journals misrepresented the actual findings of the research (World of DTC Marketing)

Regulatory Reads

• Delivering What FDA Expects in Human Factors (MDDI)
• EU Responds to Troubled Medical Devices Sector (PharmExec)
• Federal Scrutiny of Implant Hacking Continues: Is Increased Regulation on the Horizon? (QMed)
• China: New Opportunities for Growth (PharmExec)
• Once again, the FDA budget dynamic (Medical Device Daily)
• FDA Appropriations Off to a Fast Start (Alliance for a Stronger FDA)
• OMB, HHS, or FDA: Who Really Makes FDA's Decisions? (FDAzilla)
• Pharmaceutical waste management: Compliance with environmental regulations (Drug Topics)
• Mission Critical: How Translation-Focused Disease Foundations May Save Medical Research (American Enterprise Institute)
• Wireless medical device signal interference poses greater risk than hacking (Med City News)
• Pharma Battle at Standstill, but War Is Far From Over (Ad Age)

Other News and Interesting Reads

• Why NASA needs low-cost, simple medical devices (MedCity News)
• George Rathmann, First CEO of Amgen, Dies (PharmPro)
• Post-Prozac Nation: The Science and History of Treating Depression (New York Times Magazine)
• Company developing social media platform for clinical trials (Med City Mews)
• Combination Products: Marrying Materials, Medicines, and Manufacturing (QMed)
• The Wrong Way to Stop Fake Drugs (New York Times)
• Medical device wiki aids poor and under-served communities (Fierce Health IT)
• Dying Mom Posts Video for Compassionate Use; Company Agrees (ABC News)
• The Corruption Law that Scares the Bejesus Out of Corporate America (The Atlantic)