Regulatory Focus: Week in Review (21-25 May)
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: [14-18 May] [7-11 May] [1-4 May] [23-27 April] [16-20 April]
Top News Items
BREAKING UPDATE: After Setbacks, Senate Passes Amended User Fee Bill
After multiple days of political wrangling and an unexpectedly large number of amendments, the Food and Drug Administration Safety and Innovation Act has been approved in the US Senate in a 96-1 vote.
GHTF Changes Definitions of 'Medical Device' and 'IVD'
The Global Harmonization Task Force (GHTF), an international harmonization body soon to be disbanded, and replaced by the new International Medical Devices Regulators' Forum (IMDRF), has released a final guidance altering how medical devices are defined.
Report: REMS Preventing Companies From Making Generic Medicines
The Food and Drug Administration Amendments Act of 2007 allowed the US Food and Drug Administration to institute Risk Evaluation and Mitigation Strategies (REMS) for products with a high probability of misuse or dangerous side effects.
Health Canada Approves World's First Stem-cell-based Therapy
Canadian regulators have approved the world's first stem-cell-based therapy for a systemic disease, granting Maryland-based Osiris Therapeutics' Prochymal approval for the treatment of graft-versus-host disease (GVHD).
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
- Designing Efficient Clinical Trials for Glucose Sensors Focus of Upcoming FDA Meeting (Regulatory Focus)
- FCC Approves First-in-World Plan to Dedicate Spectrum to Networked Medical Devices (Regulatory Focus)
- FCC Unveils Plan to Release New Spectrum for Wireless Medical Devices (Regulatory Focus)
- Lawmakers Seek to Clarify FDA Medical App Role (CQ)
- FDA Proposes Sliding-Scale Paradigm For Obesity Device Trials (The Gray Sheet)
- Not So Special? FDA Proposal Would Damage Streamlined 510(k) Submissions Program, Firms Say (The Gray Sheet)
- As Industry Grumbles, CDRH Touts its Review Improvements (MDDI)
- Linda Kahan, Former FDA Executive, Dies at 64 (MDDI)
- Response Biomedical launches internal review of products sold to "terrorist" countries (Mass Device)
- CDRH Learn: Introduction to Medical Device Recalls: Industry Responsibilities (FDA)
Pharmaceutical and Biologics
- PhRMA: Pre-Submission Advertising Guidance Violates Free Speech Rights (Regulatory Focus)
- Report: REMS Preventing Companies From Making Generic Medicines (Regulatory Focus)
- Warning Letter Analysis: FDA Asks for Notification of Impending Drug Shortages in Newest Citations (Regulatory Focus)
- FDA Puts Off Decision on Revoking National Drug Codes for Unapproved Products (Regulatory Focus)
- FDA Approves Eleven Generic Versions of Plavix as Drug Goes Off-patent (Regulatory Focus)
- USP Plans to Launch Updated Heparin Standard to Ensure Safety (Regulatory Focus)
- USP Releases Overhaul of Impurities Testing Standards (Regulatory Focus)
- Advisory Committee Votes Against Label Expansion for J&J/Bayer's Xarelto (Regulatory Focus)
- Reviewers Express Doubts in Advance of Xarelto Review (Regulatory Focus)
- Report: Insufficient Regulatory Oversight Partially Responsible for Counterfeit Drugs (Regulatory Focus)
- Anthrax vaccine trial meets bioethicists (Nature)
- Study: Docs barring pharma reps has unexpected side effects (Fierce Pharma)
- Two Indications, One REMS: FDA Panel Debates Restricted Access For Truvada In PrEP (The Pink Sheet)
- Research Finds FDA Drug Warnings Can Have Immediate Negative Impact on Medication Adherence, Even if Not Related to Safety (PR Newswire)
Other US News
- GAO Finds FDA Employee Review Practices Lagging (Regulatory Focus)
- Poll: More Than Half of Americans Favor Increased Regulatory Authority for States (Regulatory Focus)
- US, Mexico Announce Plan to Strengthen Regulatory Cooperation (Regulatory Focus)
- 'Job-Killing' Safety Regulations Not So Job-Killing, Says Study (Regulatory Focus)
- A Multi-Faceted Approach to the Fight Against Counterfeit Medicines (The State Department)
- The Commissioner's Fellowship Program: Fostering Scientific Talent at FDA (FDA)
- FDA Looks to Consumers for Pre-approval Input (Coalition for Healthcare Communication)
Legislative Update
- After Gauntlet of Setbacks, Senate Prepares to Vote on User Fee Bill, Amendments (Regulatory Focus)
- User Fee Bill Could be Tabled in Senate After Deluge of Unrelated Amendments (Regulatory Focus)
- User Fee Bill Advances to Vote in Senate (Regulatory Focus)
- User Fee Bill Delayed in Senate as Cloture Vote Forced (Regulatory Focus)
- New Bill Hopes to Curb Drug Shortages, Price Gouging (Regulatory Focus)
The Courts
- States to FDA: Appeal Enforcement Discretion Decision (Regulatory Focus)
- Justice Department closes Medtronic probe without action (Journal-Sentinel)
- Man's Arrest for Halting His Own Tuberculosis Treatment Spurs Debate (California Healthline)
- Attorney: POM ruling is a 'stunning rejection' of FTC's stance on 'gold standard' clinical trials to support product claims
Compliance and Safety Issues
- Warning Letter Analysis: FDA Asks for Notification of Impending Drug Shortages in Newest Citations (Regulatory Focus)
- Franck's Pharmacy Issues Extensive, 'Urgent' Recall After Facility Contamination (Regulatory Focus)
- Warning Letter Analysis: Animal Food Manufacturer Cited for Marketing Violations (Regulatory Focus)
- Pfizer Recalls 653,000 Bottles of Advil After CGMP Deficiencies Cause 'Strong Odor' (Regulatory Focus)
- Marshals Seize Unapproved Drugs from Manufacturer After Purported INDA Violations (Regulatory Focus)
- Zithromax (azithromycin): FDA Statement on risk of cardiovascular death (FDA)
- Hospira Carpuject Pre-filled Cartridges - Drug Alert: Products May Contain More Than the Intended Fill Volume (FDA)
Workshops & Meetings
- FDA Announces New Meetings, Workshops (Regulatory Focus)
Deals and Acquisitions
- GSK amends HGS offer after poison pill (Pharma Times)
- AstraZeneca R&D chief predicts many more deals - FT (Pharma Times)
EU News
Regulation and Guidance
- EMA Releases 'Practical Guidance' for Implementation of Pharmacovigilance Legislation (Regulatory Focus)
- EMA Releases Guidance on Electronic Submission of Veterinary Applications (Regulatory Focus)
- Reporting requirements of individual case safety reports (ICSRs) applicable to marketing authorisation holders during the interim arrangements (Regulatory Focus)
- NCA requirements for PSUR submission during the transitional period (Regulatory Focus)
- QRD general principles regarding the SmPC information for a generic/hybrid/biosimilar product (Regulatory Focus)
Other EU News
- EU: EU/industry 223.7M-euro fund to tackle antibiotic resistance (Pharma Times)
- Greece: Exclusive: Drugmakers weigh emergency supply plan for Greece (Reuters)
- UK: NICE releases new pain relief guidelines (BBC)
- UK: NICE Fires Back at Study, Claims its Approval Times Are Steadily Falling (Regulatory Focus)
- UK: NICE Could 'Lose Most of Its Authority' Under New NHS Plan (Regulatory Focus)
- UK: Chair Appointed for UK's New Emerging Science and Bioethics Advisory Committee (Regulatory Focus)
- UK: Organizations Band Together to Form New Clinical Trial Transparency Standards (Regulatory Focus)
- UK: Govt/industry to probe generic sector sustainability (Pharma Times)
- UK: Research funders call for closer attention to guidelines on reporting animal studies (Pharma Times)
Global Regulatory News
- Australia Looking to Change Layout of Package Labeling (Regulatory Focus)
- Brazil: New Bioanalytical Standard Published (Regulatory Focus)
- Brazil: Anivsa Sets Confidentiality Criteria (Regulatory Focus)
- Brazil: Anivsa Implements Freedom of Information Law (Regulatory Focus)
- Canada: Study Calls for Canada to Boost Funding for Clinical Trials (Regulatory Focus)
- Canada: Health Canada Approves World's First Stem-Cell-Based Therapy (Regulatory Focus)
- Canada: Health Canada Consolidates Guidance on Comparative Bioavailability Standards
- Canada: Consultation - revised draft guidance document - pathway for licensing natural health products used as traditional medicines (Health Canada)
- Canada: Consultation - revised draft guidance document - pathway for licensing natural health products making modern health claims (Health Canada)
- China: China Signs MOU with the Ukraine (Regulatory Focus)
- GHTF Changes Definitions of 'Medical Device' and 'IVD' (Regulatory Focus)
- India: Report: India Moving to Regulate Biotechnology Research (Regulatory Focus)
- India: Bayer demands withdrawal of Natco Pharma's compulsory licence (The Economic Times)
- India: Drug regulation in India-the time is ripe for change (The Lancet)
- India: Delhi's drug regulation overdose (AEI)
- India: India needs to step up to be a biopharma major, says Boston Consulting Group (The Economic Times)
- World: Regulatory Agencies Attend WHO Seminar (Regulatory Focus)
Important Studies, Whitepapers and Research
- Researchers Use Google Algorithm to Find Cancer Biomarkers (Medical Daily)
- Quintiles: Quintiles' New Health Report Evaluates the Risk Equation in Biopharmaceutical Medicine (Quintiles)
- Quintiles - Your Insider's Guide to Navigate China's Emerging BioTech Industry (Quintiles)
- Herbal, Body Building, Diet Supplements Linked To Severe Liver Damage, Study (Medical Daily)
- FDA-led research team discovers an autoimmune mechanism for serious drug-induced adverse reactions (FDA)
- Reporting and Methods in Clinical Prediction Research: A Systematic Review (PLoS Medicine)
Regulatory Reads
- Navigating Name Changes and Reregistration (MDDI)
- Preparing for a US FDA Medical Device Inspection, Part 2 (EMDT)
- What Happens After Global Harmonization Goes Kaput? (MDDI)