Regulatory Focus™ > News Articles > Regulatory Recon: Is it Time to Reform FDA's Device Approval Process? (23 March 2015)

Regulatory Recon: Is it Time to Reform FDA's Device Approval Process? (23 March 2015)

Posted 23 March 2015 | By Alexander Gaffney, RAC 

Regulatory Recon: Is it Time to Reform FDA's Device Approval Process? (23 March 2015)

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

In Focus: US

  • Do the FDA’s Regulations Governing Medical Devices Need to Be Overhauled? (WSJ-$)
  • 10 Actions to Improve Radiation Protection in Medicine in the Next Decade (WHO / IAEA)
  • FDA's Ostroff: Genomics in the land of regulatory science (PubMed)
  • Gilead Warns After Hepatitis Patient on Heart Drug Dies (Bloomberg) (SCRIP-$)
  • Doctors Advocate for Passage of PATH Act (The Hill)
  • To Congress, From Pharma: Love, Hate And Fresh Ideas For 21st Century Cures (Pink Sheet-$)
  • The Curious Case Of FDA, Zarxio’s Name And The USP Monograph (Pink Sheet-$)
  • 3 Things To Watch After Sandoz's Biosimilars Win (Law 360-$) (SCRIP-$)
  • A primer on mHealth app regulations (mHealthNews)
  • FDA’s New Criminal Investigations Chief Wants Global Reach (Pink Sheet-$)

In Focus: International

  • EMA Management Board: highlights of March 2015 meeting (EMA)
  • Sanofi's Zerhouni at the EMA: More collaboration and fewer specialty medicines please (SCRIP-$)
  • New ENVI Resolution on Antimicrobial Resistance (ENVI)
  • Diabetes groups call for radical rethink of regulation governing insulin pumps (PharmJournal)
  • US FDA expects Indian pharma to seek third party audits to resolve data integrity issues (PharmaBiz)
  • Indian court blocks Glenmark's Januvia generic but it ain't over yet (SCRIP-$) (Fierce)
  • TTIP’s healthcare chapter to focus on medicines approval (EurActiv)
  • WHO Report on Substandard, Falsified and Counterfeit Medicines (WHO)

Learn About--and Help Shape--FDA's Draft Combo Products GMP Guidance

  • When it comes to combination products, more regulations can mean more difficulties for regulatory professionals. That's why we've teamed up with the Combination Products Coalition (CPC) to offer a full day interactive program focused on FDA's newest draft guidance on Good Manufacturing Practices (GMPs) for combination products. Learn from FDA experts and industry veterans in this unique experience that will help agency regulators to shape and clarify the final guidance document. Register for the program here.

US: Pharmaceuticals and Biotechnology

  • Gilead Warns After Hepatitis Patient on Heart Drug Dies (Bloomberg) (SCRIP-$)
  • Doctors Advocate for Passage of PATH Act (The Hill)
  • To Congress, From Pharma: Love, Hate And Fresh Ideas For 21st Century Cures (Pink Sheet-$)
  • The Curious Case Of FDA, Zarxio’s Name And The USP Monograph (Pink Sheet-$)
  • Secondary pharmacology data to assess potential off-target activity of new drugs: a regulatory perspective (PubMed)
  • Cancer drug shortage sends patients on grim search (NY Post)
  • Monitoring the Safety of Biosimilars by Managed Care Organizations: A Practical Approach (AdverseEvents)
  • FDA, DEA May Act More In Unison After Prodding From Congress, GAO (Pink Sheet-$)
  • Well-Defined and Reliable Clinical Outcome Assessments for Pediatric Crohn's Disease: A Critical Need for Drug Development (PubMed)
  • 3 Things To Watch After Sandoz's Biosimilars Win (Law 360-$) (SCRIP-$)
  • Namenda antitrust suit heats up in NY court (BioPharmaDive)
  • Gilead Attacks FCA Suit's Claims Of Shoddy Drugmaking (Law 360-$)
  • J&J's Janssen scores partial victory in second Risperdal trial (Reuters)
  • Case Against Chelsea Therapeutics Over Regulatory Filing of Northera Returns (Ruling)
  • Juror's Google Search May Trigger New Tylenol Death Trial (Law 360-$)
  • Re-Evaluating Ethical Concerns in Planned Emergency Research Involving Critically Ill Patients: An Interpretation of the Guidance Document from the United States Food and Drug Administration (PubMed)
  • Blood test for patients on acne medication deemed unnecessary (Press)

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

  • Pfizer's Xeljanz hits targets in PhIII psoriasis trial (PharmaTimes) (Press)
  • Celgene Presents PhIII Data on Oral OTEZLA (apremilast) Long-Term Safety and Efficacy Data in Patients with Moderate to Severe Plaque Psoriasis (Press)
  • MEI Pharma's cancer drug misses main goals in mid-stage study (Reuters)
  • Pfizer, Lilly to resume late-stage study testing pain drug (Reuters) (Press) (Fierce)
  • Vertex Announces Data from 12-Week Phase 2 Safety Study of VX-661 in Combination with Ivacaftor in People with Cystic Fibrosis Who Have Two Copies of the F508del Mutation (Press) (The Street)
  • Celgene’s Oral Mongersen Could Be Game-Changer In Crohn’s Disease (Pink Sheet-$)
  • Novartis' Cosentyx two-year data shows sustained effect and favorable safety profile in psoriasis patients (Press)
  • Dilaforette gets FDA orphan drug status for sevuparin to treat sickle-cell disease (PBR)

US: Pharmaceuticals and Biotechnology: General

  • Evaluating Expected Costs and Benefits of Granting Access to New Treatments on the Basis of Progression-Free Survival in Non–Small-Cell Lung Cancer (JAMA)
  • PhRMA presses for 340B changes (BioCentury)
  • Comparative Effectiveness Of MS Drugs, Biosimilars On PCORI’s Radar (Pink Sheet-$)
  • Bristol, Sanofi and Novartis drugs to shine among 2015 launches (Reuters)
  • HHS Chief Weighs in on Precision Medicine (Medium)

US: Medical Devices

  • Do the FDA’s Regulations Governing Medical Devices Need to Be Overhauled? (WSJ-$)
  • 10 Actions to Improve Radiation Protection in Medicine in the Next Decade (WHO / IAEA)
  • FDA's Ostroff: Genomics in the land of regulatory science (PubMed)
  • FDA's draft guidance on medical device accessories: Potential considerations for manufacturers (Mass Device) (MDDI)
  • A primer on mHealth app regulations (mHealthNews)
  • Murray Presses FDA, Calls for Full Review of Practices Surrounding Medical Scopes Linked to Drug-Resistant Infections (Senate)
  • AMP submits written comments to FDA on next-generation sequencing regulation (Press)
  • Digital Pathology Association Weighs-In on First FDA Draft Guidance for Whole Slide Imaging (Press)
  • Genetic tests’ online claims may not give the full story (NECIR)
  • Experts Warn of Serious Risks From Common IV Devices (Infection Control Today)
  • NovaBone Products Receives 501(k) Clearance for Wound Dressing (Press)

US: Dietary Supplements

  • FDA Analysis Reveals More Tainted Weight Loss Pills (MPR)
  • Supplement Groups Move from Science to Politics as Attorneys General Probe Industry (NPI)
  • FTC Sends Refund Checks Totaling More Than $416,000 to Consumers Who Lost Money Buying “Body Slimming” Creams that Were Deceptively Marketed (FTC)
  • Bayer Satisfies DoJ ‘Need To Know’ About Probiotic Claim Studies (Tan Sheet-$)

US: Assorted And Government

  • FDA’s New Criminal Investigations Chief Wants Global Reach (Pink Sheet-$)
  • FDA Communications Webinar Provides Insight into FDA’s Operations (FDA Life)
  • Senate Schedules Hearing on R&D Environment (Senate)
  • The Case for More Funding at FDA (Strengthen FDA)
  • Government Committee to Investigate Problem of Prescription Opioid Abuse (E&C)
  • Twenty groups write Congress, no fast track without public access to trade agreement negotiating texts (KEI)
  • Advisory Committee to Discuss Pediatric, Privacy and Harmonization Issues in Research (Tarius)
  • Does your wrinkle cream really work? FDA warns about false claims (NBC) (Tan Sheet-$)

Upcoming Meetings and Events

Europe

  • EMA Management Board: highlights of March 2015 meeting (EMA)
  • Sanofi's Zerhouni at the EMA: More collaboration and fewer specialty medicines please (SCRIP-$)
  • New ENVI Resolution on Antimicrobial Resistance (ENVI)
  • Diabetes groups call for radical rethink of regulation governing insulin pumps (PharmJournal)
  • Farmaindustria defends the non-interchangeability principle for biologic and biosimilar medicines (PharmaLetter-$)
  • Draft guideline for the testing and evaluation of the efficacy of antiparasitic substances for the treatment and prevention of tick and flea infestation in dogs and cats (EMA)
  • Reflection paper on promotion of pharmacovigilance reporting (EMA)
  • VICH GL53: Electronic exchange of documents: electronic file format (EMA)
  • Draft reflection paper on poorly extractable and or non-radiolabelled substances (EMA)
  • Kamada Awarded European Orphan Drug Designation for Its Alpha-1 Antitrypsin to Treat Graft-versus-Host Disease (Press)
  • MSD Animal Health Receives Positive Opinion from European Medicines Agency for Mixed Use of Two of Its Poultry Vaccines (Press)
  • IQWiG now finds added benefit for Provenge (PharmaLetter-$)
  • BD Gains CE Mark for STD MDx Assays (GenomeWeb)
  • EMA releases new version of Formatted Table Template for Procedural Submission Cover Letters (Exalon)

India

  • US FDA expects Indian pharma to seek third party audits to resolve data integrity issues (PharmaBiz)
  • Indian court blocks Glenmark's Januvia generic but it ain't over yet (SCRIP-$) (Fierce)
  • Gujarat FDCA alerts NPPA on shortage of human albumin seeking immediate intervention (PharmaBiz) (PharmaBiz)
  • FDA’S Visit To India Calls To Mind 2014 Commitments To Cooperate (Two-Four Insight)
  • AIMED, QCI & NABCB form steering committee to roll out voluntary quality certification for devices (PharmaBiz)
  • Dr Reddy's to launch Hepatitis C drug in India (India Times)
  • Medical devices industry in India underinvested: WHO (India Times) (PharmaBiz)

Other International

  • TTIP’s healthcare chapter to focus on medicines approval (EurActiv)
  • WHO Report on Substandard, Falsified and Counterfeit Medicines (WHO)
  • WHO Report on Antimicrobial Resistance (WHO)
  • Lebanon seizes half a ton of radioactive sanitary towels (Reuters)

Clinical Trials

  • Sharing clinical trial data (BioMedCentral)
  • National team led by Tufts CTSI finds navigators are integral to clinical research process (Press)
  • N.J. Senate Approves Bill Calling for Clinical Trials Working Group (Thompson's)

General Regulatory And Interesting Articles

  • For The Love Of Pork: Antibiotic Use On Farms Skyrockets Worldwide (NPR)
  • Is Sewage Treatment Arming New Forms of Super-Bacteria? (MotherBoard)
  • Cattle parasite study points to possible way to fight malaria (Reuters)

Regulatory Reconnaissance #519 – 23 March 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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