Regulatory Focus: Week in Review (2-6 April)
Regulatory Focus is proud to bring you 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.
Missed last week's Week in Review? You can find it here.
Top News Items
Proposal Would Overhaul FDA Accelerated Approval Pathway
A new piece of legislation released in discussion draft form by the Senate Health, Education, Labor and Pensions Committee aims to "overhaul" the US Food and Drug Administration (FDA) Accelerated Approval pathway, reports The Hill. More »
EMA's Abadie Resigns as Chair of CHMP
The European Medicines Agency (EMA) announced 4 April that effective immediately, Eric Abadie, chair of the Committee for Medicinal Products for Human Use (CHMP), was resigning from his position. More »
New FDA Program to Boost Regulatory Science, Speed Drug Development
The US Food and Drug Administration (FDA) announced the launch of a new program intended to advance clinical trial design and endpoints to boost regulatory science and facilitate expedited drug development. More »
Global Global API Inspection Scheme Ramps Up, Seeks New Members
The participants in an active pharmaceutical ingredient (API) inspection program involving many of the world's premiere global regulatory bodies recently announced the intent to standardize the inspection schemes of its member nations and advance "administrative simplification." More »
United States News
Guidance and Draft Guidance for Industry
- New FDA Guidance on Evaluation of Veterinary Stability Data (Regulatory Focus)
- New Medical Device Guidance on Information Requests Released by FDA (Regulatory Focus)
FDA Information
- Shuren's Senate Testimony Yields Wealth of Insight (Regulatory Focus)
- Woodcock Testifies on PDUFA, FDA Drug Approval Performance (Regulatory Focus)
- Proposed FDA Rules for UDIs, Laser Products Continue to Languish at OMB (Regulatory Focus)
- New FDA Standard on Cargo Theft Released (Regulatory Focus)
- Report: Clashes Between White House, FDA Frequent (Regulatory Focus)
- FDA-Backed Collaborative Research Fund Off to Slow, Controversial Start (Regulatory Focus)
- FDA, ISMP Announce New Initiative to Reduce Medication Errors (Regulatory Focus)
- Global API Inspection Scheme Continues to Ramp Up, Calls for Additional Members (Regulatory Focus)
- IOM: Boost Foreign Regulatory Capacity to Ensure Drug Safety (Regulatory Focus)
- FDA Creates Program to Boost Regulatory Science, Speed Drug Development (Regulatory Focus)
- Joint FDA, Chinese Training Helping to Boost Product Safety (Regulatory Focus)
- FDA Close to Approving J&J Drug Via Animal Rule Pathway (Regulatory Focus)
- Industry Groups Have Concerns With Off-Label Drug, Device Info Draft Guidance (Bloomberg)
- FDA MAPP - 4652.1 Property Management Program (FDA)
- FDA Medication Guides Updated 30 March (FDA)
- Panel Skeptical on Home Anthrax Rx Kits (MedPage Today)
- MedSun: Newsletter #71, April 2012 (FDA)
- FDA Statement about Product Quality of Parenteral Vancomycin Products (FDA)
- FDA's Third Annual Report to Congress on 505(q) Citizen Petitions; Agency Says the Jury is Still Out on the Petition Law, But There are Concerns (FDA Law Blog)
Other US News
- New Batch of Counterfeit Cancer Drug Avastin Found in US (Regulatory Focus)
- US, Mexico and Canada Move to Harmonize Regulations (Regulatory Focus)
- Americans Cutting Back on Drugs and Doctor Visits (NYTimes)
- Rule to align privacy regulations on its way (Modern Healthcare)
- Experts Recommend Single Registry to Oversee Kidney Transplant Donations (New York Times)
- C-Path: Request for Proposal - PRO Consortium Functional Dyspepsia Working Group - Content Validity Stage (C-Path)
- Federal regulators approve pharmacy benefit manager merger despite congressional objections (The Hill)
- Painkiller sales soar around US, fuel addiction (AP)
- With new plant, Ranbaxy back in force in North America (Fierce Pharma Manufacturing)
- Ranbaxy starts generic Lipitor shipments from India (Reuters)
- FDA Continues to Study BPA (FDA)
- After AHCJ protest, HHS stipulates public meetings are open to media (AHCJ)
Congressional Actions and Political News
- GAIN Act Included in Early Senate PDUFA Discussion Draft (Regulatory Focus)
- Bill Looks to Make Changes to FDA's Accelerated Approval Pathway (Regulatory Focus)
- Dem blasts FDA for rejecting petition to ban food container chemical BPA (The Hill)
- Romney Talks FDA, Medical Device Regulation (Regulatory Focus)
- HELP Committee Leaders Aim To Prevent Controversial Add-Ons To User Fee Bill (The Gray Sheet)
- FTC Chairman Jon Leibowitz Confirmed for Second Term as Commissioner (FTC)
- Generic Exclusivity Forfeiture Fix Bill Introduced to Elevate OGD and Address ANDA Backlog (FDA Lawyers Blog)
- Senators Lean On CMS To Meet Sunshine Deadline (Pharmalot)
The Courts
- Pfizer Executives Sued Under Securities Laws for Allegedly Concealing Clinical Trials Results (Regulatory Focus)
- Medtronic settles sharehodlers' lawsuit over Infuse spine implant (MassDevice)
- Rx Fraud Cases: Beat Goes On As Whistleblowers Pursue Lesser Allegations (The Pink Sheet)
- FDA: April 2, 2012: Equitable Sharing of $500 Million Google Foreiture Approved (FDA)
- Reaffirming Earlier Ruling, WTO Orders Obama Administration to Drop Flavored Cigarette Ban (Regulatory Focus)
- FDA Doesn't Have the Discretion It Thought It Had (Drug and Device Law)
Workshops & Meetings
- Meetings: Peripheral and Central Nervous System Drugs Advisory Committee (FDA)
- Brookings Roundtable on Active Medical Product Surveillance (FDA)
- Blood Products Advisory Committee (FDA)
- General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee (FDA)
Agency Information Collection Activities; Proposals, Submissions, and Approvals
- Agency Information Collection Activities; Proposals, Submissions, and Approvals: Blood Establishment Registration and Product Listing, Form FDA 2830 (FDA)
- Request for Information on Prescription Medication Adherence (HHS)
Warning Letters & Prominent Recalls
- Thoratec's HeartMate II correction dubbed a Class I recall (Mass Device)
- H & H Wholesale Services, Inc. (CGMP/QSR/Medical Devices/Adulterated/Misbranded)
- Ogenix Corporation (CGMP/QSR/Medical Devices/Adulterated)
- Kentron Health Care, Inc. (Medical Device Reporting/Misbranded)
- NuSil Technology LLC (CGMP for Active Pharmaceutical Ingredient (API)/Adulterated)
- NeuroTrax Israel Ltd. (Premarket Approval/Medical Device/Adulterated)
- Edge Biologicals, Inc. (CGMP/QSR/Medical Devices/Adulterated)
- LifeSouth Community Blood Centers, Inc. (CGMP for Blood & Blood Products/Adulterated)
European News
News and Other EMA Information
- EMA's Rasi Seeks Greater Industry Participation (Regulatory Focus)
- EMA's Abadie Resigns as Chair of CHMP (Regulatory Focus)
- EMA Tightens Conflict-of-Interest Policies (Regulatory Focus)
- EMA Asks for Feedback on Pharmacovigilance Legislation Implementation (Regulatory Focus)
- EMA Releases Presentations, Videos from Pharmacovigilance Stakeholder Meeting (Regulatory Focus)
- EMA Announces Planned Office, Website Closings Starting 5 April (Regulatory Focus)
- EMA - Human Medicines Highlights (March 2012) (EMA)
- EMA - Template for submission of comments on the list of Union reference dates and frequency of submission of periodic safety update reports (EMA)
- EMA - List of European Union (EU) reference dates and frequency of submission of periodic safety update reports - Introductory cover note to the public consultation of the EU reference date list (EMA)
- EMA - Draft list of Union reference dates and frequency of submission of periodic safety update reports (EMA)
- EMA - Application form for European Medicines Agency certificates of medicinal products (EMA)
- EMA- Abbreviation of names of days on calendarised blisters (EMA)
- EMA - List of official languages per country (EMA)
- EMA - Work instructions for recording, validation and production of certificates of medicinal products (EMA)
- EMA - Notification on increase of the administrative charge for EMA certificates of medicinal products (EMA)
- EMA - Overview of implementing rules of the Staff Regulations signed by the Management Board chair during the period from 7 October 2011 to 29 February 2012 (EMA)
- EMA - European Union Telematics operations report: 33rd report for period ending 31 December 2011 (EMA)
- EMA - Performance of the Agency's scientific procedures: 2011 report for medicinal products for human use (EMA)
- EMA - Presentation - Adaptive licensing: a useful approach for drug licensing in the European Union?
- England: Healthcare leaders agree new pharma joint working guidelines (Pharma Times)
- England: British Pharmacopoeia Commission proposes changes to inhaled product monographs (MHRA)
- MHRA: reminder of Article 23a obligations and the 'Sunset Clause' (MHRA)
- MHRA: Report: Second Instance of Fake Avastin Highlights MHRA Troubles (Regulatory Focus)
- MHRA Publishes New Edition of 'Blue Guide' on Medicinal Advertising, Promotion (Regulatory Focus)
- MHRA Advises Surgeons Against Using Some Metal-on-Metal Hip Implants (Regulatory Focus)
- MHRA Announces 'Procedural Changes' for Submission of Labels, Patient Leaflets (Regulatory Focus)
- MHRA: Information sent to healthcare professionals in March about the safety of medicines (MHRA)
- MHRA: New Clinical Practice Database Will Lead to New Ways to Conduct Clinical Trials (Regulatory Focus)
- Poland's cheap drug law breaks EU rules, says Court of Justice (Pharma Times)
Work Instructions, SOPs, and Regulatory and Procedural Guidelines
- EMA: European Medicines Agency Adopts Two Alzheimers Biomarkers (EMA)
- EMA - Standard operating procedure for certificates of medicinal products (EMA)
Meetings and Workshops
- 9th annual EC/WHO Senior Officials Meeting (European Commission)
- Workshop on vaccine development against the Schmallenberg virus (EMA)
- EPHA ANNUAL CONFERENCE 2012 Restructuring health systems: How to promote health in times of austerity? (EPHA)
Global Regulatory News
- Africa: New Initiative Aims to Harmonize Africa's Regulations (Regulatory Focus)
- Australia: Medicines Safety Update, Volume 3, Number 2, April 2012 (TGA)
- Australia: Reporting medical device adverse incidents (TGA)
- Australia: Reporting Adverse Drug Reactions (TGA)
- Australia: Australian Government funding for biologicals (TGA)
- Australia: Australian Adverse Event Database Hits Milestone (TGA)
- Brazil: New Rules on Pharmacies and Wholesale Distributors (Regulatory Focus / Reglink)
- Brazil: New criteria for priority drug review (Regulatory Focus / Reglink)
- Brazil: Antibiotics Subject To Narcotics Supervision System (Regulatory Focus / Reglink)
- Brazil: New Manual For Labeling National Health Service Drugs (Regulatory Focus / Reglink)
- Canada: New eCTD Guidance In Effect (Regulatory Focus / Reglink)
- Canada: Canada Vigilance Adverse Reaction Online Database (Health Canada)
- Canada: Consultation Document - Draft Guidance for Industry: Creation of the Canadian Module 1 Backbone (Health Canada)
- Canada: Draft Canadian Module 1 Schema Version 2.1 (Health Canada)
- Canada: Guidance Document: Patented Medicines (Notice of Compliance) Regulations (Health Canada)
- Canada: Guidance on Classification of Observations for Inspection of Cells, Tissues and Organs Establishments (GUI-0101) (Health Canada)
- Canada: Canadians "waiting two-and-a-half years for new drugs" (Pharma Times)
- Health Canada Announces Fee Changes For Drugs, Devices (Health Canada)
- Canada: Guidance Document on the Application for a Certificate of a Pharmaceutical Product (GUI-0024) (Health Canada)
- China: China Launches National Campaign Against Counterfeit Drugs (Regulatory Focus / Reglink)
- ICH: ICH Releases Updated MedDRA Guidance (ICH)
- PIC/S: New PIC/S Aide-Memoire: Aide-Memoire on Assessment of Quality Risk Management Implementation (PIC/S)
Other News and Interesting Reads
- FDA Model Floated for Regulating Financial Products (Slate)
- Make your own medical device! Why not? (CNN)
- When Medicine Really Gets Personal: The DIY Clinical Trial (WSJ)
- Insight: Chasing cheaper cancer drugs (Reuters)
- Strategic Reserve Stockpiling: A Proposal To Prevent Critical Drug Shortages (Health Affairs Blog)
- America's Gardasil Problem: How Politics Poison Public Health (Forbes)
- A History of FDA Inaction on Animal Antibiotics (Pro Publica)
- Lethal injection drug access could put executions on hold (iWatch News)
- Chinese Medicine Goes Under the Microscope (WSJ)
- Integrative Fire-Fighting (Science-Based Medicine)
- Oh, A Wise Guy, Eh? Then Stoogesta Is For You (Pharmalot)
- Backup Health Care Plan Involves Nation Sharing One Big Jar Of Ointment (The Onion)
Important Studies, Whitepapers and Research
- Paper: Regulatory Cost-Benefit Analysis Best Done Out of Spotlight (Regulatory Focus)
- Paper Looks to Establish Best Practices for Evaluating Effectiveness of Regulations (Regulatory Focus)
- Ex-Amgen drug researcher calls out questionable cancer findings (Fierce Biotech)
- Unveiling the mystery of online pharmacies: An audit study (American Enterprise Institute)
- Improving Quality Of Life For Lab Mice Leads To Better Science (Medical News Today)
- Scientific Journals Plan To Publish Contentious Bird Flu Research (NPR)
- Gene Maps Are No Cure-All (WSJ)
- Drugs can be Potentially Made Inside Patients Through New Field of Chemistry (Med India)
- Study shows investigative sites see revenue, clinical trial volume growth amid signs of recovery (Center Watch)
- UK Biobank opens up data to researchers (PharmaTimes)
- McKinsey: Capturing the Brazilian pharma opportunity (McKinsey)
- Lives at Risk: The Local Impact of Federal "Regulatory Reform" Proposals (Demos)
- Study: Metal hips don't heighten cancer risks (Fierce Medical Devices)
- Scientists Link Gene Mutation to Autism Risk (New York Times)
- Pharma companies need to help patients adopt healthier behaviour: E&Y (India Times)