Regulatory Focus™ > News Articles > Regulatory Recon: Calls for Margaret Hamburg's Resignation Shrugged off by FDA (24 September 2014)

Regulatory Recon: Calls for Margaret Hamburg's Resignation Shrugged off by FDA (24 September 2014)

Posted 24 September 2014 | By Alexander Gaffney, RAC 

Regulatory Recon: Calls for Margaret Hamburg's Resignation Shrugged off by FDA (24 September 2014)

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

This fall, regulatory professionals from across the globe will come together to learn, connect and share at the Regulatory Affairs Professionals Society’s 2014 RAPS: The Regulatory Convergence, 27 September-1 October, Austin, TX.  Register here, or check out some of the mostnews-worthy sessions here.

In Focus: US

  • Anti-addiction groups want FDA chief to resign (AP) (WaPo)
  • USP -- Highlighting Its Legal Role In Naming -- Backs WHO Plan For Distinguishable Biologic Names (IHP-$)
  • Janet Woodcock Manages to Win Praise from Both Sides of the Congressional Aisle (RPM Report)
  • FDA warns doctors to beware fake drug distributors (AP) (EMPR) (Pink Sheet-$) (FDA)
  • FDA gives green light to Celgene pill Otezla for psoriasis (Pharma Times) (RTT) (Medscape) (Press) (SCRIP-$) (BioCentury)
  • The FDA wants to talk about medical device cybersecurity (WaPo)
  • First Audit Under The Harmonized Single-Audit Program Slated For This Week (Gray Sheet-$)
  • FDA Awards Seattle Children's Hospital $1.6M for Trial on Infant Heart Defects (News-Medical)

In Focus: International

  • WHO: Ebola Vaccine Could be Ready by Year-End (AP)
  • Ombudsman vows 'robust' action against EU secrecy (EU Observer)
  • Invasion Of The Unannounced EU Notified Body Auditors (Law 360-$)
  • NICE plans 'no' for ulcerative colitis drugs (Pharma Times)
  • NGOs call upon Modi not to commit flexibilities in Indian Patents Act during his US visit (PharmaBiz)
  • Chinese drug producers to be graded, some blacklisted (ECNS) (PharmAsia-$)
  • Global Gaps in Standards Threaten Biosimilar Development (PharmExec) (PharmAsia-$)

US: Pharmaceuticals and Biotechnology

  • Anti-addiction groups want FDA chief to resign (AP) (WaPo)
  • USP -- Highlighting Its Legal Role In Naming -- Backs WHO Plan For Distinguishable Biologic Names (IHP-$)
  • Janet Woodcock Manages to Win Praise from Both Sides of the Congressional Aisle (RPM Report)
  • FDA warns doctors to beware fake drug distributors (AP) (EMPR) (Pink Sheet-$) (FDA)
  • FDA gives green light to Celgene pill Otezla for psoriasis (Pharma Times) (RTT) (Medscape) (Press) (SCRIP-$) (BioCentury)
  • FDA Releases REMS Standardization Report (FDA)
  • FDA Finally Posts DMD Guidance for Comment in Federal Register (FDA)
  • Don't Follow FDA Guidance on Use of Google Adword Site Links (Pharma Marketing Blog)
  • Use Patents Can Be Useful: The Case of Rescued Drugs (SSRN)
  • Pharmacies banned from compounding for docs without prescription (Outsourcing Pharma-$)
  • FDA Says Sliding Scale of Biosimilarity Does Not Represent Approval Standards (FDA News-$)
  • US FDA Advisory Committee Hears Pediatric-Focused Safety Reviews (Tarius)
  • Three encouraging steps towards new antibiotics (FDA)
  • Why the FTC Lawsuit over Pay-To-Delay Deals Matters (Pharmalot)
  • Regulatory Compliance Chief Worry in Supply Chain: UPS Study (Biopharm International)
  • NIH funds next phase of Tissue Chip for Drug Screening program (NIH)
  • New supplemental awards apply sex and gender lens to NIH-funded research (NIH)
  • Accutane MDL Judge Tosses Roche Warning Label Suit (Law 360-$)
  • Comments of KEI regarding the White House OSTP call for comments on its Strategy for American Innovation (KEI)

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

  • FDA accepts Lundbeck, Otsuka filing of schizophrenia drug (Reuters) (Press)
  • Epirus tests generic version of Remicade as it awaits clarity from FDA on biosimilars (BioFlash)
  • FDA fast track designation for AstraZeneca’s MEDI3902 (Pharma Letter-$)
  • Galmed Pharmaceuticals Announces U.S. FDA Approval of Fast Track Designation of Aramchol for the Treatment of NASH (Press)
  • Amgen competitor Opko plans year-end NDA for Rayaldee (SCRIP-$)
  • MedImmune Receives FDA Fast Track Designation for Development of MEDI3902 for Prevention of Nosocomial Pneumonia (Press)
  • Elusys' anthrax product approaches market (SCRIP-$)
  • OPKO's Second Rayaldee Phase 3 Trial Meets Primary Endpoints (Press)
  • ZS Pharma jumps on ZS-9 Phase III data (BioCentury) (SCRIP-$)
  • Gilead’s Investigational Tenofovir Alafenamide (TAF)-Based Single Tablet HIV Regimen Meets 48-Week Primary Objective in Two Phase 3 Studies (Press)

US: Pharmaceuticals and Biotechnology: General

  • To Gather Drug Data, a Health Start-Up Turns to Consumers (NYTimes)
  • Man gets 25 years for violent last-mile robberies (Fierce)

US: Medical Devices

  • The FDA wants to talk about medical device cybersecurity (WaPo)
  • First Audit Under The Harmonized Single-Audit Program Slated For This Week (Gray Sheet-$)
  • The DOJ & cGMP Enforcement: What The Medtech Industry Can Learn From Pharma's Folly (MedDeviceOnline)
  • Companies Already Working to Help Hospitals Better Utilize UDIs (Press)
  • August 2014 510(k) Clearances (FDA)
  • Atossa Genetics' ForeCYTE Breast Aspirator Found Not Substantially Equivalent (Press)
  • Anesthesia Safety Products Announces FDA De Novo Clearance to Market the AirPurge System for Automatic Removal of Air Bubbles in I.V. Lines (Press)
  • Life Spine Announces FDA Clearance of LONG BOW Expandable Lateral Interbody System (Press)
  • Nanovis Spine, LLC receives FDA 510(k) clearance of its novel FortiCoreTM cervical and lumbar interbody fusion device platform (Press)
  • Cynosure Receives Expanded FDA Clearance to Market PicoSure for Treatment of Wrinkles (Press)

US: Dietary Supplements

  • FTC: Weight-Loss Claims Among Inadequate Advertising Disclosures (NPI)
  • GNC, USPlabs Settle Class Action Over Recalled Supplements (Law 360-$)
  • SmartX “Brain Supplement” Firm Should Rethink Its Product Claims – NAD (Tan Sheet-$)
  • The Dangerous Mix of Adolescents and Dietary Supplements for Weight Loss and Muscle Building: Legal Strategies for State Action (PubMed)

US: Assorted And Government

  • FDA Awards Seattle Children's Hospital $1.6M for Trial on Infant Heart Defects (News-Medical)
  • Health Regulators as Data Stewards (SSRN)
  • ACRO, Dana Farber seek more info on FDA informed consent draft guideline (Outsourcing Pharma)

Upcoming Meetings

Ebola Outbreak

  • WHO: Ebola Vaccine Could be Ready by Year-End (AP)
  • Fast-tracked Ebola studies put Tekmira, Mapp and Sarepta in the spotlight (Fierce)
  • Inovio Pharmaceuticals Ebola Vaccine Moving into Human Trial with GeneOne Life Science (Press)
  • US hospitals unprepared to handle Ebola waste (Reuters)

Europe

  • Ombudsman vows 'robust' action against EU secrecy (EU Observer)
  • Invasion Of The Unannounced EU Notified Body Auditors (Law 360-$)
  • Switzerland squeezes drug prices, risking Roche/Novartis loyalty (SCRIP-$)
  • ICH guideline M8 on eCTD – questions and answers (EMA)
  • ICH guideline M7 on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk (EMA)
  • Avoiding duplication of clinical trials in children (EMA)
  • New antibiotic for hospital-acquired pneumonia now available in Europe (Pharm Journal)
  • NICE plans 'no' for ulcerative colitis drugs (Pharma Times)

India

  • NGOs call upon Modi not to commit flexibilities in Indian Patents Act during his US visit (PharmaBiz)
  • Pharma industry must learn from mistakes and give fitting reply to regulators: Sudhanshu Pandey (PharmaBiz)

China

  • Food, drug producers to be graded, some blacklisted (ECNS) (PharmAsia-$)
  • Real world study: A look at BMS' China Sprycel registry (SCRIP-$)
  • Heat’s on over inaccurate thermometers (ECNS)
  • China finds irregularities in TCM products (ECNS)

Japan

  • Gilead Submits New Drug Application to Japan’s PMDA for Fixed-Dose Combination of Ledipasvir/Sofosbuvir for Chronic Hepatitis C Genotype 1 Infection (Press)

Canada

  • Canadian Antitrust Chief Vows To Tackle Pay-For-Delay Deals (Law 360-$)

Other International

  • Global Gaps in Standards Threaten Biosimilar Development (PharmExec) (PharmAsia-$)
  • Mexico and Brazil: A tale of two very different supplement markets (NI-USA)

Clinical Trials

  • ACRO, Dana Farber seek more info on FDA informed consent draft guideline (Outsourcing Pharma)

General Regulatory And Interesting Articles

  • Patient organisations: accelerating orphan drug development (PharmaPhorum)
  • Tiny DARPA implants could give humans self-healing power (CBS)
  • Celgene Global Health and DNDi expand collaboration to identify innovative therapies to benefit patients with neglected tropical diseases (Press)

Regulatory Reconnaissance #406 – 24 September 2014

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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