Regulatory Focus™ > News Articles > Regulatory Recon: A Diet Drug and the Case Study on How Not to Handle Clinical Data (13 May 2015)

Regulatory Recon: A Diet Drug and the Case Study on How Not to Handle Clinical Data (13 May 2015)

Posted 13 May 2015 | By Alexander Gaffney, RAC

Regulatory Recon: A Diet Drug and the Case Study on How Not to Handle Clinical Data (13 May 2015)

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

In Focus: US

In Focus: International

  • Study finds numerous drug combinations sold in India lack regulatory approval (Reuters) (PLoS)
  • Indian Health Ministry recommends post-trial access of NCE to trial participants (PharmaBiz)
  • Disputes Emerge on African Ebola Drug Trials (WSJ-$)
  • EMA: Draft guideline on clinical development of fixed combination medicinal products (EMA)
  • WHO takes on board IMDRF principles in IVD pre-qualification program overhaul (SCRIP RA-$)
  • Carving the Path to Regulatory Harmonization in Africa (Thompson Reuters)

Take Your Regulatory Career to the Next Level With Executive Training

  • Now more than ever, senior regulatory professionals must bridge science, regulation, business and strategy. RAPS’ Executive Development Program at the Kellogg School of Management is the only program of its kind that caters exclusively to experienced regulatory professionals. It is an exceptional opportunity to strengthen your management and leadership skills over four intensive days in an intimate learning environment. Register for the Executive Development Program here.

US: Pharmaceuticals and Biotechnology

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

  • One of Takeda's big cancer bets flops in a Phase III lymphoma trial (Fierce)
  • Pain rockets on positive results; plans Remoxy resubmission (SCRIP-$)
  • Therabron Therapeutics Secures New Orphan Designation for the Prevention of Bronchopulmonary Dysplasia (Press)

US: Pharmaceuticals and Biotechnology: General

  • Number of Americans using $100,000 in medicines triples: Express Scripts (Reuters)
  • Texas Keeps Suppliers Of Execution Drugs A Secret (AP)
  • Want to know a secret? Pharma's patient services are going to waste (Fierce)

US: Medical Devices

  • As FDA Duodenoscope Safety Meeting Approaches, One Firm Isn't Planning Changes (Gray Sheet-$)
  • Seattle hospital joins 'superbug' lawsuit against scope manufacturer (Reuters)
  • Boston Scientific settles mesh lawsuit (MassDevice)
  • Medtronic's Arctic Front Advance ST wins FDA approval (MassDevice) (Fierce) (Press)
  • Precision medicine and the FDA's draft guidance on laboratory-developed tests (Nature-$)
  • Asthma app study data on ResearchKit shows mixed results for patient engagement (MedCityNews)
  • BD Receives FDA Clearance for a Novel Infusion Set with BD FlowSmart Technology to Enhance the Use of Insulin Pumps (Press)

US: Assorted And Government

  • 21st Century Cures Legislative Phase to Continue on 14 May 2015 (E&C) (The Hill)
  • Senators plan rival bill on medical cures; not expected for several months (The Hill)
  • Brand Drug Makers Protested Cures Exclusivity Provisions Requiring NIH Donations (IHP-$)
  • Interest groups seek to add goodies to fast-moving FDA overhaul bill (ModernHealthcare-$)
  • 21st Century Clinical Trials for 21st Century Cures (Medium)
  • Breaking Down BIMO (FDA Law Blog)

Upcoming Meetings and Events

Ebola Outbreak

  • Disputes Emerge on African Ebola Drug Trials (WSJ-$)
  • FDA Advisory Committee Discusses the Development and Licensure of Ebola Vaccines (Tarius) (Pink Sheet-$)

Europe

  • Draft guideline on clinical development of fixed combination medicinal products (EMA)
  • AZ combination COPD therapy secures okay outcome from IQWiG (SCRIP-$)
  • France Implements Further Restrictions on Oral Isotretinoin (ANSM)

India

  • Study finds numerous drug combinations sold in India lack regulatory approval (Reuters) (PLoS)
  • Health Ministry recommends post-trial access of NCE to trial participants (PharmaBiz)
  • Gujarat FDCA chief to meet Vietnamese, African regulators to discuss issues on loan license (PharmaBiz)

China

  • Indian industry asks Modi to press for access to China's drug market (Fierce)

Australia

  • Australia says orphan drugs earning big bucks for pharma, proposes removing fee waivers (SCRIP RA-$)
  • Submissions and TGA response: Metoclopramide: proposed advisory statement for medicines (TGA)

Other International

  • WHO takes on board IMDRF principles in IVD pre-qualification program overhaul (SCRIP RA-$)
  • Carving the Path to Regulatory Harmonization in Africa (Thompson Reuters)
  • The revision of ISO 31000 on risk management has started (ISO)

Clinical Trials

  • Re-engineering clinical trials: A 'tipping point' vs. incremental change (Outsourcing Pharma)

General Regulatory And Interesting Articles

  • A Profile of the "King of Pills," Raymond Schinazi (Science)
  • How DNA sequencing is transforming the hunt for new drugs (Reuters)

Regulatory Reconnaissance #556 – 13 May 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

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe