Regulatory Focus™ > News Articles > Regulatory Recon: EMA Defends its Clinical Trial Redaction Policy (11 February 2015)

Regulatory Recon: EMA Defends its Clinical Trial Redaction Policy (11 February 2015)

Posted 11 February 2015 | By Alexander Gaffney, RAC

Regulatory Recon: EMA Defends its Clinical Trial Redaction Policy (11 February 2015)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

In Focus: US

  • Industry ties could be at issue for possible FDA pick Robert Califf (Washington Examiner)
  • Man gets 3-year prison sentence for fake drug study (Chicago Sun Times)
  • FDA Draft Guidance on Disclosing Risk Information Discourages Companies From Meeting Current Regulatory Requirements (FDA Law Blog)
  • ANDA Review Times Will Not Come Down In Next Two Years, FDA Predicts (Pink Sheet-$)
  • New Dosages of Old Drugs Are Used to Raise Their Prices (NYTimes)
  • Kyle Bass' war against the US pharmaceutical industry has officially begun (Business Insider)
  • FDA's View on 3-D Printing Medical Devices (MDDI)
  • FDA warns Staar Surgical again over California plant (Mass Device)
  • How Not to Test a Dietary Supplement (The New Yorker)
  • Why You Don't see Many FDA Staff at Meetings Anymore (Washington Post)

In Focus: International

  • EMA responds to EU Ombudsman on AbbVie redactions (BioCentury) (EMA) (AllTrials) (BioPharma-Reporter) (SCRIP-$)
  • What the EU Commission thinks of a device think-tank, annual effectiveness reports and Eudamed (Clinica-$)
  • Task force for medical device expected to submit its report this week (PharmaBiz)
  • Canadian government to require drug shortage notice (Reuters) (Canoe)
  • Major Pushback Against Investigation Which Implied Gardasil Vaccine was Unsafe (Blog) (Vox)

Sponsored Message: Learn About China's New Medical Device Regulations

  • China’s growing medical device market is the 3rd largest in the world. Learn about the new medical device regulations that went into effect on 1 October 2014 and how they impact foreign medical device manufacturers registering their products in China. The webcast will also focus on the challenges and best practices for executing clinical trials in China and how to avoid them.
  • Join RAPS, Wednesday, 18 February for New China Medical Device Regulations: Best Practices for Clinical Trials.

US: Pharmaceuticals and Biotechnology

  • FDA Draft Guidance on Disclosing Risk Information Discourages Companies From Meeting Current Regulatory Requirements (FDA Law Blog)
  • ANDA Review Times Will Not Come Down In Next Two Years, FDA Predicts (Pink Sheet-$)
  • Man gets 3-year prison sentence for fake drug study (Chicago Sun Times)
  • Next Steps for Patient-Centered Drug Development: Room for More Input, With Limits (RPM Report-$)
  • Pacira Pharmaceuticals, Inc. Announces Resolution of Warning Letter with FDA’s Office of Prescription Drug Promotion (Press)
  • FDA AdComm to Discuss Amgen's BLA for an Oncolytic Immunotherapy (FDA)
  • FDA Rejects Auxilium Bid To Hamstring Rival Product (Law 360-$)
  • FDA puts off Mylan's Nexium generic, giving Teva's version free rein (Fierce)
  • FDA analysis correlates ORR with PFS in lung cancer (BioCentury) (PubMed)
  • Amgen moves to block potential Zarxio launch (BioCentury) (EP Vantage-$) (Nature)
  • An FDA oncology analysis of antibody-drug conjugates (PubMed)
  • FDA plans meeting on drug-induced liver injury (BioCentury)
  • FDA Renews Charter for Seven Advisory Committees (FDA)
  • Neoliberal technocracy: Explaining how and why the US Food and Drug Administration has championed pharmacogenomics. (PubMed)
  • Clinical experience with intravenous zanamivir under an Emergency IND program in the United States (2011-2014) (PubMed)
  • Hamburg: Measles Vaccine Is Safe and Effective – And Should Be Used (FDA) (Reuters)
  • Sen. Warren’s “War on Pharma”: Rhetorical Blast, But Remarkably Limited Objectives (RPM Report-$)
  • Managing Off-Label Drug Use (Harvard BOH)
  • Tennessee Bill Would Establish Definition for Interchangeable Biological Product (Scout)
  • Indiana House Unanimously Passes ‘Right to Try’ Bill to Effectively Nullify Some FDA Restrictions (10th Amendment Center)
  • Should FDA be OK With Approving a Drug That's Worse Than a Standard of Treatment so Long as it's Cheaper? (Fortune)
  • MerLion announces FDA approval of new swimmers' ear drug (Press)
  • FDA: Vogelxo Therapeutically Equivalent to Testim (MPR)

US: Pharmaceuticals and Biotechnology: Clinical Study Results, Filings and Designations

  • Oncolytics Biotech Inc. Announces Receipt of Orphan Drug Designation from the U.S. FDA for Ovarian Cancer (Press)
  • Anthera jumps 25% on blisibimod update, new endpoint (SCRIP-$)
  • Baxter Presents Additional Data from Pivotal Study of BAX 855, Extended Half-Life Investigational Recombinant FVIII Based on ADVATE FOR Hemophilia A (Press)

US: Pharmaceuticals and Biotechnology: General

  • New Dosages of Old Drugs Are Used to Raise Their Prices (NYTimes)
  • Kyle Bass' war against the US pharmaceutical industry has officially begun (Business Insider)
  • Senators Voice Support for Vaccines at Hearing (Warren) (Alexander) (MedPage Today) (SCRIP-$)
  • Can Pharma Premium Pricing Model Endure? (Financial Times-$)
  • GPhA Creates Biosimilars Division; Will New Members Follow? (Pink Sheet-$)
  • Momenta's Craig Wheeler re-elected GPhA chair (DSN)

US: Medical Devices

  • FDA's View on 3-D Printing Medical Devices (MDDI)
  • FDA warns Staar Surgical again over California plant (Mass Device)
  • Public, Academic Labs Press FDA To Be Flexible In LDT Requirements (Gray Sheet-$)
  • AMP Issues Position Statement on Direct-to-Consumer Genetic Testing; Supports DTC Testing When Information Is Actionable for Patients (Press)
  • Days after permanent injunction, Maquet is whacked with another FDA recall (Fierce)
  • CDC: Opportunity To Collaborate in the Evaluation of Simplified Nucleic Acid Tests for Detecting and Quantifying HIV (CDC)
  • Covidien Devices Recalled Over Labeling Issue (FDA)
  • Sanuthera Submits Serenity Device to FDA for 510(k) Clearance (Press)

US: Dietary Supplements

  • Supplement manufacturer slapped with permanent injunction after series of warning letters (NI-USA)
  • How Not to Test a Dietary Supplement (The New Yorker)
  • Fabricant: Supplement industry needs to move out of the crosshairs (Newhope360)
  • Nationwide study reports shifts in Americans’ use of natural products (NIH) (WaPo)
  • Study shows iron supplementation after blood donation shortens hemoglobin recovery time (NIH)

US: Assorted And Government

  • Industry ties could be at issue for possible FDA pick Robert Califf (Washington Examiner)
  • Why You Don't see Many FDA Staff at Meetings Anymore (Washington Post)
  • Chronic-Fatigue Syndrome Gets Controversial Redefinition (SciAm) (AP)
  • PhRMA Salutes Outgoing FDA Commissioner’s Leadership, Looks Forward to Continued Collaboration (PhRMA)

Upcoming Meetings

Ebola Outbreak

  • Sarepta sees promising signs that antisense drug can guard against Ebola (Fierce) (Reuters)
  • Obama to bring back most U.S. troops fighting Ebola in Africa (Reuters)

Europe

India

  • Task force for medical device expected to submit its report this week (PharmaBiz)
  • Karnataka Vision Group ready with draft of Rare Diseases and Orphan Drugs Development Act (PharmaBiz)

Canada

  • Canadian government to require drug shortage notice (Reuters) (Canoe)
  • Major Pushback Against Investigation Which Implied Gardasil Vaccine was Unsafe (Blog) (Vox)
  • Ontario Health Innovation Council Releases Report to Government (MEDEC)
  • MEDEC Applauds the Government of Canada’s Commitment to Regulate Commercially Reprocessed Single-Use Medical Devices (MEDEC)

Clinical Trials

  • Former Minnesota Governor Wants University to Upgrade Trial Oversight (Pharmalot)

General Regulatory And Interesting Articles

  • The Coming Boom In Brain Medicines (Forbes)
  • Hate pills so much you’d give two years of life to avoid them? (Washington Post)
  • Travelers’ antibiotics may do more harm than good (Reuters)
  • Pharma’s reputation ‘is worsening among patients’ (Pharmafile)

Regulatory Reconnaissance #491 – 11 February 2015

Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory news stories from around the globe. Each weekday morning, we aim to bring you the latest highlights of new approvals, meetings, legal and political developments, regulations and guidance, and the latest trends with the potential to impact regulatory affairs professionals and the industry in which they work.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @AlecGaffney or send him an email at news@raps.org.

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.


Categories: Recon, Regulatory News

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