Regulatory Focus: Week in Review (26-30 March)

Regulatory Focus is proud to bring you our first-ever 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.

Top News Items

GAO: Medical Device Reviews Taking Longer Despite FDA Meeting Goals

The US Government Accountability Office released a report Thursday (29 March) indicating it found the US Food and Drug Administration (FDA) to be meeting its performance goals for medical device reviews, but that overall medical device review time was trending upward. More »

EU Parliament Refuses to Approve EMA 2010 Spending, 2013 Budget
The European Parliament is refusing to approve of how the European Medicines Agency (EMA) spent its fiscal year 2010 budget-a move that is delaying the approval of EMA's fiscal year 2013 budget, reports PharmaTimes. More »

Analysis: Resubmissions After Third Round of FDA Review Not Worth Effort
An analysis by the Biotechnology Industry Organization (BIO) of 748 new drug applications (NDAs) and biologics license applications (BLAs) shows a nearly 20% increase in the rate of approvals for second-round submissions in response to a first-round complete response letter (CRL). More »

EMA Strengthens Conflict of Interest Policies
The European Medicines Agency (EMA) announced Monday, 26 March, its Management Board has endorsed a proposal from EMA Executive Director Guido Rasi to strengthen conflict of interest policies surrounding its scientific committee members and experts. More »

US News

Guidance and Draft Guidance for Industry

• FDA Releases New Guidance For Industry for Benefit:Risk Evaluations in PMAs, De Novo Classifications  (Regulatory Focus)
• New Draft Guidance on Bioequivalence Recommendations for Iron Sucrose Injection  (Regulatory Focus)
• FDA Establishes Class II Controls for Full Field Mammography System  (Regulatory Focus)
• Deadline for Mandatory Submission of Drug Sample Information to FDA Closes Soon (Regulatory Focus)
• Draft Guidances; Correction: Development of Biosimilar Products; Public Hearing (FDA)
• Immunology and Microbiology Devices: Classification of Norovirus Serological Reagents; Correction (FDA)

News and Other FDA Information

• FDA Considers Expanding Definition of Nonprescription Drugs (Regulatory Focus)
• FDA approves Omontys to treat anemia in adult patients on dialysis (FDA)
• EPA Case Could Imperil FDA Warning Letters (Regulatory Focus)
• IOM Report Calls for FDA Involvement in 'Omics' Test Development (Regulatory Focus)
• CDRH Releases New Learning Module on ISO 13485:2003 (Regulatory Focus)
• FDA Revises MAPP For Regulatory Project Management Site Tours (Regulatory Focus)
• New Animal Drugs for Minor Use and Minor Species; CFR Correction (FDA)
• BIO Analysis: Resubmissions After Third Round of FDA Review Not Worth the Effort (Regulatory Focus)
• AIDS Group Calls for Hamburg's Resignation (Regulatory Focus)
• FDA Enforcement Report for March 28, 2012 (FDA)
• FDA Seeks to Standardize CDER's Telephone Availability (Regulatory Focus)
• Corrigan: FDA Transforming to a Global Agency, Success Depends on Partnerships (Regulatory Focus)
• GAO: Medical Device Reviews Taking Longer Despite FDA Meeting Goals (Regulatory Focus)
• Policy On High-Risk Biological Research Tightened (NPR)
• Obesity drugs need heart studies, U.S. advisers say (Reuters)
• US Marshals seize unapproved and misbranded drug products at Missouri distributor (FDA)

Congressional Actions

• Senate HELP Committee - FDA User Fee Agreements: Strengthening FDA and the Medical Products Industry for the Benefit of Patients (Regulatory Focus)
• Congressman Calls for Closure of Medical Device 'Loophole' in Report (Regulatory Focus)
• Senator Ayotte Calls for Repeal of Medical Device Tax (MDDI Online)
• Senators Draft Bill to Expedite Drug Approval (Regulatory Focus)
• House Energy and Commerce Committee - Examining the Current State of Cosmetics (Regulatory Focus)
• Cosmetics Safety Enhancement Act of 2012 (H.R.4262) (THOMAS)
• Report warns of deep cuts to medical research if budget sequester goes through (The Hill)
• PREA, BPCA Reauthorization Bill Introduced in House of Representatives (Regulatory Focus)
• Senator Plans to Introduce Legislation Reversing Mensing Decision (Regulatory Focus)
• Recent Congressional Health Policy Hearings (Health Industry Washington Watch)
• Jumpstart Our Business Startups Act Passes Senate (GovTrack)
• Lawmakers: Prescription drug abuse fight needs federal hand (The Hill)
• Blumenthal, Corker, Gingrey Praise Inclusion Of Gain Act In Discussion Draft Of FDA User Fee Reauthorization Bill
  Group: Industry Lobbying Tarnishing FDA Integrity (Regulatory Focus)

The Courts

• (1) US court rejects AstraZeneca's Seroquel lawsuit against FDA (PM Live)
• (2) Judge (again) denies AZ's bid to stop Seroquel copies, but chides FDA (Fierce Pharma)
• (3) AZ boosted as US judge backs Seroquel XR patent (PharmaTimes)
• After Prometheus Case, SCOTUS Sends Gene Patent Ruling Back to Lower Court (Regulatory Focus)
• Court Bars FDA from Importing Drug Used in Death Penalty (Regulatory Focus)
• Court rejects Obama plea to reconsider bone marrow ruling (LA Times)
• Day One: Supreme Court Preview (Regulatory Focus)
• Day Two: Supreme Court Preview and Day One Review (Regulatory Focus)
• Day Three: Supreme Court Preview and Day Two Review (Regulatory Focus)

Workshops & Meetings

• FDA Plans Meeting on Metal-on-Metal Hip Implants (Regulatory Focus)
• Full Information From FDA OTC Switch Meeting Released (Regulatory Focus)
• Workshop: Development of Animal Models of Pregnancy to Address Medical Countermeasures for Influenza in the 'At Risk' Population of Pregnant Women, etc. (FDA)
• Meetings: Gastroenterology and Urology Devices Panel of Medical Devices Advisory Committee (FDA)
• Meetings: Circulatory System Devices Panel of Medical Devices Advisory Committee (FDA)
• IOM: Developing Biomarker-based Tools for Cancer Screening, Diagnosis, and Treatment (IOM)
• Agency Information Collection Activities; Proposals, Submissions, and Approvals: Food Contact Substance Notification Program (FDA)
• Draft Guidances; Correction: Development of Biosimilar Products; Public Hearing (FDA)
• Meetings: Pediatric Advisory Committee (FDA)

Agency Information Collection Activities; Proposals, Submissions, and Approvals

• Financial Disclosure by Clinical Investigators (FDA)
• Request for Comments on Issues of Privacy and Access With Regard to Human Genome Sequence Data (President's Council on Bioethics)

Warning Letters & Prominent Recalls

• Celexa (citalopram hydrobromide) - Drug Safety Communication: Revised Recommendations, Potential Risk of Abnormal Heart Rhythms (FDA)
• Bad Wire in Heart Device Led to 22 Deaths, Study Says (New York Times)
• Lucero Medical, LLC - Device/Adulterated/Misbranded (FDA)
• IntelliCell Biosciences, Inc. - CGMP/Current Good Tissue Practice(CGTP) (FDA)
• Farma Quimia S.A. de C.V. - CGMP/Finished Pharmaceuticals/Adulterated (FDA)
• Laboratorios Jaloma S.A. de C.V. - CGMP/Finished Pharmaceuticals/Adulterated (FDA)
• Cosmed S.R.L. - CGMP for Medical Devices/QSR/Medical Device Reporting/Misbranded (FDA)
• Pax-All Manufacturing Inc. - CGMP/Finished Pharmaceuticals/Adulterated (FDA)
• Osypka Medical GmbH - CGMP for Medical Devices/QSR/Reporting/Adulterated/Misbranded (FDA)
• Heartway Medical Products Co., Ltd. - CGMP for Medical Devices/QSR/Reporting/Adulterated (FDA)
• SystemsOne, LLC - CGMP for Medical Devices/QSR/Adulterated/Misbranded (FDA)
• Shanghai Apolo Medical Technology Co., Ltd - Adulterated Device (FDA)
• Orthopedic Alliance - CGMP/QSR/Adulterated/Misbranded (FDA)
• Spinal Solutiions, LLC - CGMP/QSR/Adulterated/Misbranded (FDA)

EU News

News and Other EMA Information

• European Medicines Agency Management Board strengthens conflicts of interest policies and transparency (Regulatory Focus)
• Clinical Trials Register Information for EU Now Available Through WHO (Regulatory Focus)
• EMA, HMA Release Joint Guidance Document on Commercially Confidential Information in MAAs (Regulatory Focus)
• European Parliament Refuses to Approve EMA's 2010 Spending, 2013 Budget (Regulatory Focus)
• NICE looking into unlicensed and off-label drug use (InPharm)
• MHRA Launches Research Service to Provide More Clinical Research Data to Industry (Regulatory Focus)
• MHRA introduces more flexibility for the submission format of labels and patient leaflets (MHRA)
• EMA Application, MAH Fees Set to Rise 3.1% on 1 April (Regulatory Focus)

Scientific Guidelines

• Concept paper on no need for revision of the guideline on medicinal products for the treatment of Alzheimer's disease and other dementias, adopted (EMA)
• SCENIHR - Request for a scientific opinion: Health effects of nanomaterials used in Medical Devices (EMA)
• SCENIHR - Request for an updated scientific opinion on the safety of PIP silicone breast implants (EMA)
• Concept paper on the need for revision of the points to consider on clinical investigation of medicinal products for the treatment of Amyotrophic Lateral Sclerosis (EMA)
• Concept paper on guidance for DNA vaccines (EMA)

Work Instructions, SOPs, and Regulatory and Procedural Guidelines

• Work instructions for data acquisition and control and maintenance of business pipeline database (medicines for human use), adopted (EMA)
• Standard operating procedure for operation of the business pipeline activity for medicines for human use (EMA)
• Work instructions for organisation and coordination of business pipeline meetings with pharmaceutical companies (medicines for human use), adopted (EMA)
• Declaration on the qualification of an enterprise as a micro, small or medium-sized enterprise (SME), adopted (EMA)
• Standard operating procedure for management of periodic safety update reports (PSURs) for centrally authorised veterinary medicinal products (EMA)

Global Regulatory News

• IMDRF Announces Open Stakeholder Meeting (Regulatory Focus)
• Japan Applies for PIC/S Membership (PIC/S Scheme)
• Minutes of AHWP Secretariat Meeting, Singapore, 28 Feb 2012 (AHWP)
• Health Canada: Nearly One-in-ten Trials Inspected Noncompliant (Regulatory Focus)

Other News

• Roche to sell cheaper cancer drugs in India (Chicago Tribune)
• CRO Cetero files for bankruptcy protection 8 months after FDA fake document accusations (Outsourcing Pharma)
• Medical device makers decry cost of new tax (The Hill)
• U.S. questions India's IP regime after Nexavar move (Fierce Pharma)
• Indian industry seeks clear regulatory pathway for diagnostics kits (Biospectrum Asia)
• Drug and Health Product Industry Spent $700 Million on Lobbying (Union of Concerned Scientists)

Important Studies, Science News and Whitepapers

• In cancer science, many "discoveries" don't hold up (Reuters)
• Annual Reviews: Advertising of Prescription-Only Medicines to the Public: Does Evidence of Benefit Counterbalance Harm? (Annual Reviews)
• Study: Cancer Trial Leaflets Too Long, Confusing to Patients (Regulatory Focus)
• Oncology trials take 50% longer than other therapeutics; report (Outsourcing Pharma)
• Out-of-Pocket Medication Costs and Use of Medications and Health Care Services Among Children With Asthma (JAMA)
• Consumer Reports Investigates: Dangerous medical devices (Consumer Reports)
• Position Paper: Research and Development for Poverty-Related and Neglected Diseases (European AIDS Treatment Group)
• Study: Poorly Written Medication Warnings Missed by Busy Doctors (Regulatory Focus)
• Failure rates of stemmed metal-on-metal hip replacements: analysis of data from the National Joint Registry of England and Wales (Lancet)
• Massive Genome, Cancer Databases Made Public (Regulatory Focus)