Regulatory Focus: Week in Review (28 May - 1 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 the 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: [21-25 May] [14-18 May] [7-11 May] [1-4 May] [23-27 April]
Top News Items
House Overwhelmingly Passes User Fee Legislation
The US House of Representatives voted overwhelmingly to support the Food and Drug Administration Reform Act (FDARA), sending the bill to a conference committee for an ultimate merger with the Senate's Food and Drug Administration Safety and Innovation Act (FDASIA).
EMA Releases First Revision to Biosimilar Quality Guidelines Since 2006
The European Medicines Agency (EMA) announced it has released a newly-revised guideline on the quality of biosimilar medicines and is soliciting comments. The 31 May 2012 guidance, Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues, updates a previous guidance released in 2006.
FDA Aims to Accelerate Approval of Breast Cancer Drugs
The US Food and Drug Administration (FDA) released new draft guidance for industry, providing an intended outline for sponsors hoping to utilize an accelerated approval pathway for drug-based preoperative breast cancer treatments.
New EMA-run Website Looks to Boost Adverse Event Reporting Transparency
The European Medicines Agency (EMA) is looking to enhance its transparency measures surrounding the receipt and publication of adverse event reports for all medicines authorized in the European Economic Area through a brand-new website.
Regulatory Focus Features
- How Safe Are Biosimilars? Implications of FDA and EMA Guidances and European Experience since 2006 (Regulatory Focus)
- ClinicalTrials.gov: Requirements and Implementation Strategies (Regulatory Focus)
- Demystifying Electronic Data Standards for Clinical and Nonclinical Studies (Regulatory Focus)
- Considering Risk Evaluation and Mitigation Strategies (REMS) (Regulatory Focus)
US News
Medical Devices
- FDA Releases Guidance on How to Qualify for Small Business User Fee Waivers (Regulatory Focus)
- MQSA Alternative Standard #21: Correction Period When Components of the Agfa CR Full Field Digital Mammography Imaging System Fail Quality Control Tests (FDA)
- FDA Pilot Program Will Streamline Process and Benefit Consumers, OEMs, even the FDA Itself (MDDI)
- Exemptions from Premarket: Wheelchair Elevator (FDA)
- Exemptions from Premarket: Powered Patient Transport (FDA)
Pharmaceutical and Biologics
- FDA Releases New Guidance for Clinical Evaluation of Irritable Bowel Syndrome Drugs (Regulatory Focus)
- FDA Releases Draft Guidance for Accelerated Approval of Breast Cancer Treatments (Regulatory Focus)
- Antimicrobial Resistance Monitoring Policy Updated by FDA (Regulatory Focus)
- Advisory Committee Lends Limited Support to Pfizer's Tafamadis (Regulatory Focus)
- FDA Biologics Sterility Testing Rule Finalized In Just 10 Months (The Pink Sheet Daily)
- An Emerging REMS Dilemma: Qnexa, Truvada - and Korlym (The RPM Report)
- FDA knocks back J&J's one-pill Prezista for HIV (Pharma Times)
- Drug bans hamper brain research, says neuroscientist (Reuters)
- Biosimilars, Year One: FDA Estimates 2 Applications, 1,720 Hours Of Work (The Pink Sheet)
- States crack down on prescription-drug "doctor shopping" (Reuters)
Other US News
- White House Wants Agencies to Develop Mobile Technologies, Open APIs (Regulatory Focus)
- Researchers Expect Physician Sunshine Act to Have Little Effect (Regulatory Focus)
- IOM Explores Regulatory Hurdles of Animal Research (Regulatory Focus)
- Footage of FDA's Patient network Annual Meeting (FDA)
- POM aims arch ads at FTC tormentors (Medical Marketing & Media)
Legislative Update
- Report: Lobbying Pushes Bioavailability Testing Provisions Into House User Fee Bill (Regulatory Focus)
- House Overwhelmingly Passes User Fee Legislation (Regulatory Focus)
- Senate Easily Clears Amended User Fee Bill (Regulatory Focus)
- House to Vote on User Fee Reauthorization, Medical Device Tax Repeal Bills (Regulatory Focus)
- New Bill Would Standardize Package Inserts (Regulatory Focus)
- House Version of user Fee Legislation Gets Major Boost from CBO (Regulatory Focus)
- House Releases Previously-unreleased Email Exchanges Between White House, PhRMA (Regulatory Focus)
- Amended Text of the Food and Drug Administration Reform Act (House)
- FDA User Fee Work Continues Following House Passage (Pink Sheet Daily)
- Big Pharma sweats outcome of Supreme Court ruling (Fierce Pharma)
- FDAAA Impact Analysis (Year 4): The REMS Retreat Continues - For Now (The RPM Report)
The Courts
- Judge's Order Banning Enforcement Discretion Appealed by FDA (Regulatory Focus)
- FDA's PLAIR Program Collides With Hatch-Waxman (FDA Law Blog)
Compliance and Safety Issues
- 'Misleading' Patient Perspective Smacked Down by FDA in Untitled Letter (Regulatory Focus)
- Warning Letter Analysis: Device Companies, Tissue Bank Hit Hard for Deficiencies (Regulatory Focus)
- Consumers Warned of Fake Adderall in US (Regulatory Focus)
- Data Reporting Mistake Hits Vertex Pharmaceuticals' Stock (Regulatory Focus)
- Bodybuilding.com, LLC and Jeremy DeLuca Plead Guilty in Federal Court to Violating FDCA (FDA)
- FDA Safety Communication: Dialysate Concentrates and Alkali Dosing Errors with Hemodialysis (FDA)
- Palm Beach Man Sentenced for Mislabeling Medical Test Kits (FDA)
- Benzocaine and Babies: Not a Good Mix (FDA)
Workshops & Meetings
Deals and Acquisitions
- GSK wants to replace all of HGS board (Pharma Times)
EU News
Regulation and Guidance
- EMA Releases First Revision to Biosimilar Quality Guidelines Since 2006 (Regulatory Focus)
- EMA Announces Adoption of Q11 Guidance (Regulatory Focus)
- EMA Proposes Changes to Existing Clinical Trial Guideline on Multiplicity Issues (Regulatory Focus)
- EMA Releases New Draft Guideline on Ensuring the Quality of Animal-based Biotechnology (Regulatory Focus)
- Draft Guideline on Venous Thromboembolism Products Released by EMA (Regulatory Focus)
EMA Information
- New EMA-Run Website Looks to Boost Adverse Event Reporting Transparency (Regulatory Focus)
- EMA Recommends Vertex's Cystic Fibrosis Drug Kalydeco (Regulatory Focus)
- European Medicines Agency updates patient and prescriber information for Pradaxa (EMA)
- QRD general principles regarding the SmPC information for a generic/hybrid/biosimilar product (EMA)
- Europe clears Roche drug after contamination scare (Reuters)
- GSK receives positive opinion from European CHMP for pazopanib in the treatment of patients with certain advanced soft tissue sarcomas (PharmPro)
- European Medicines Agency confirms positive benefit-risk balance of MabThera (EMA)
- Takeda's delayed diabetes drug alogliptin gets European filing (PMLiVE)
- Pfizer's Inlyta backed by EMA for kidney cancer in EU (PMLiVE)
- Substances considered as not falling within the scope of Regulation (EC) No. 470/2009, with regard to residues of veterinary medicinal products in foodstuffs of animal origin (EMA)
- Fifth stakeholder forum on the implementation of the new pharmacovigilance legislation (EMA)
- European Medicines Agency workshop for micro, small and medium-sized enterprises (SMEs) - Focus on pharmacovigilance (EMA)
- Reporting requirements of Individual Case Safety Reports (ICSRs) applicable to marketing authorisation holders during the interim arrangements (EMA)
Other EU News
- EU: European Union opens probe of parallel drug trade (SF Gate)
- EU: Stem Cell Research and Patenting (ENVI)
- EU: EU herbal product registrations drop, "through the floor" (Nutra Ingredients)
- EU: Innovative Medicines Initiative Launches €224 million program to combat antibiotic resistance (IMI)
- UK: Xarelto, Pradaxa Difficult To Separate After Positive NICE Final Guidance (The Pink Sheet Daily)
- UK: Contractor audit failings jump into MHRA top 10 deficiencies (Outsourcing Pharma)
- UK: ABPI launches guide to help pharma understand the NHS (PMLiVE)
- Ireland: Ireland to impose reference pricing and increase generic substitution (PMLiVE)
Global Regulatory News
- Brazil: New IVD Guidance Aims to Assist Small Businesses (Regulatory Focus)
- Brazil: New IVD Guidance Aims to Assist Small Businesses (Regulatory Focus)
- Canada: Notice: Categorization of Therapeutic Products at the Device / Drug Interface (Health Canada)
- Canada: Notice to Stakeholders - Release of the Draft Guidance Interpreting the Blood Regulations for stakeholder consultation (Health Canada)
- China: China's Biostar says it has replaced 5M tainted capsules (Fierce Pharma Manufacturing)
- India: India encourages gelatin makers to bring it on (Fierce Pharma Manufacturing)
- South Korea: Regulators Increase Online Data Transparency (Regulatory Focus)
- South Korea: Korea FDA To Consider Substantial Reduction To IND Timeframe (The Pink Sheet Daily)
- Spain: 25% of medications do not include any alerts regarding their interaction with a medical condition (Europa Press)
Important Studies, Whitepapers and Research
- Behind The Numbers Report: 2013 (PwC)
- Prescription Drug Shortages: Reconsidering the Role of Medicare Payment Policies (RAND)
- Pathological Complete Response and Accelerated Drug Approval in Early Breast Cancer (NEJM)
- Guinea pigs in human form: clinical trials in unethical settings (The Lancet)
- Imaging Biomarkers in Oncology Drug Development (Quintiles)
- Lifecycle Modeling and Simulation - Current Practice and Future Impact on Healthcare Innovation and Delivery (Quintiles)
- Poisoning Kills More Americans Than Car Crashes, Report Says (Bloomberg)
- Researcher: Trials Overlook Cancer Spread (The Scientist)
- Docs Slower to Drop 'Black Box' Drugs When Access to Drug Reps Is Restricted (Science Daily)
- Dangers Linked to 'Pharmaceuticalization' of 21st Century Highlighted (Med India)
- Text messages increase medication adherence rate (Drug Topics)
- Overdiagnosis poses significant threat to human health (EurekAlert)
- Misuse of over-the-counter pain medication is potential health threat (EurekAlert)
Regulatory Reads
- Foreign Corrupt Practices Act: Life Science Companies and Emerging Markets (Policy and Medicine)
- There's a Medical App for That-Or Not (WSJ)
- Prescription Drug Shortages: Reconsidering The Role Of Medicare Payment Policies (Health Affairs)