Regulatory Focus™ > News Articles > Regulatory Recon: A Farewell to FDA's Margaret Hamburg (2 April 2015)

Regulatory Recon: A Farewell to FDA's Margaret Hamburg (2 April 2015)

Posted 02 April 2015 | By Alexander Gaffney, RAC 

Regulatory Recon: A Farewell to FDA's Margaret Hamburg (2 April 2015)

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

In Focus: US

  • Margaret Hamburg Ends Six-Year Run As FDA Commissioner (NPR)
  • FDA announces PRO compendium (BioCentury)
  • FDA to Discuss Strategies to Use Computational Modeling and Simulation in Device Development (FDA)
  • Medtronic Attempts A Do-Over On Renal Denervation (MDDI) (Mass Device)
  • How to Protect Your Medical Device Against Cyber Threats (MDDI)
  • State prosecutors seek congressional probe of herbal supplement industry (AP)
  • FDA to Withdraw Approval for Arsenic-Based Drug Used in Poultry (Food Safety news) (FDA)
  • Lessons from FDA's 2014 Enforcement in Social Media (DH Academy)

In Focus: International

  • Pfizer to Cease Vaccine Sales Business in China (WSJ-$) (Reuters) (Bloomberg)
  • Japan opens early access pathway (BioCentury)
  • European Court of Justice introduces ‘product batch’ liability (MedicalDevicesLegal)
  • EMA confirms that access to clinical study reports for HTA purposes is fair (SCRIP RA-$)
  • Concept paper on clinical investigation of medicinal products for the treatment of Axial Spondyloarthritis (EMA)
  • The BMJ weighs in on Avastin/Lucentis debate (PMLive)
  • Regulatory Approach to Manufacturing Cell/Gene Therapies (IPQ-$)

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

  • FDA to Withdraw Approval for Arsenic-Based Drug Used in Poultry (Food Safety news) (FDA)
  • Lessons from FDA's 2014 Enforcement in Social Media (DH Academy)
  • Analysis of Vertex's Upcoming Advisory Committee Meeting (Tarius)
  • Sun Pharma settles Angiomax litigation with The Medicines Company (India Times)
  • Achaogen’s Plazomicin Development Program Saved By FDA Faith In Limited Use (Pink Sheet-$)
  • Florida Right to Try Bill Advances (Press)
  • Nevada Right to Try Bill Advances (Press)
  • U.S. FDA Grants Expanded Labeling Claim to On-X Life Technologies, Reducing Blood-Thinning Requirements for Heart Valve Patients (Press)

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

  • PledPharma jumps 20% on PhII chemotherapy-induced nerve damage data (Fierce)
  • Perosphere Receives FDA Fast Track Designation for Investigational Anticoagulant Reversal Agent PER977 (Press)
  • Enzalutamide Demonstrates Statistically Significant Improvement in Progression Free Survival Compared With Bicalutamide in Strive Trial (Press)
  • FDA grants orphan drug status for Idera's IMO-8400 to treat diffuse large B-cell lymphoma (PBR)

US: Pharmaceuticals and Biotechnology: General

  • Walgreen sues Endo, claiming pay-for-delay on generic drug (Bloomberg)

US: Medical Devices

  • FDA to Discuss Strategies to Use Computational Modeling and Simulation in Device Development (FDA)
  • Medtronic Attempts A Do-Over On Renal Denervation (MDDI) (Mass Device)
  • How to Protect Your Medical Device Against Cyber Threats (MDDI)
  • Who’s to Blame for Superbug Deaths Linked to Endoscopes? (MDDI)
  • New FDA clearance will bring Sense4Baby into the home (MobiHealthNews)
  • LENSAR Receives FDA Clearance of Five New Performance Application Upgrades to the LENSAR Laser System (Press)
  • NEC Display Solutions Receives FDA 510(K) Clearance on MD322C8 Review Monitor (Press)
  • Alere Receives FDA Clearance for Alere i Strep A Rapid Molecular Test (Press)

US: Dietary Supplements

  • State prosecutors seek congressional probe of herbal supplement industry (AP)
  • Nutrex, GNC, Others Sued Over Falsely Marketed Supplements (Law 360-$)
  • Will the Anticipated NDI Guidance Hint at IP Protection? (NPI)
  • FDA To Hold Public Hearing On Homeopathy Products (Forbes)

US: Assorted And Government

  • Margaret Hamburg Ends Six-Year Run As FDA Commissioner (NPR)
  • FDA announces PRO compendium (BioCentury)
  • Sunshine Act Compliance Data Extended by Two Days (FDA law Blog)
  • FDA's Weekly Enforcement Report (FDA)
  • Lowy becomes NCI's acting director (BioCentury)

Upcoming Meetings and Events

Ebola Outbreak

Europe

  • European Court of Justice introduces ‘product batch’ liability (MedicalDevicesLegal)
  • EMA confirms that access to clinical study reports for HTA purposes is fair (SCRIP RA-$)
  • Concept paper on clinical investigation of medicinal products for the treatment of Axial Spondyloarthritis (EMA)
  • The BMJ weighs in on Avastin/Lucentis debate (PMLive)
  • Novartis accused of Lucentis ‘campaign’ against Avastin (Pharmafile)
  • Russian government approves new plan for pharma import substitution (Pharma Letter-$)
  • Baxter gets CE mark for connected, at-home dialysis system (Fierce)
  • Miliband Says Drugmakers Exempt From U.K. Health Profit-Cap Plan (Bloomberg)

Japan

China

  • Pfizer to Cease Vaccine Sales Business in China (WSJ-$) (Reuters) (Bloomberg)
  • Wuxi-MedImmune JV sees CFDA accept RA mAb for review (Fierce)

Australia

  • Guidance 15: Biopharmaceutic studies (TGA)

Other International

  • Regulatory Approach to Manufacturing and Control of Cell/Gene Therapies Draws International Discussion (IPQ-$)

Clinical Trials

  • Johns Hopkins Faces $1B Suit Over ‘Horrific’ Syphilis Study (Law 360-$)

General Regulatory And Interesting Articles

  • Health IT biz develops regulatory compliance hub for life science companies, but can it compete with CROs? (MedCityNews)
  • Drugged Down: Nearly 19 Percent of Us Take Drugs Daily (NBC)
  • We Should Have a Better Condom by Now. Here’s Why We Don’t. (Slate)
  • Unpowered Exoskeleton Makes Walking Easier (MedGadget)

Regulatory Reconnaissance #527 – 2 April 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