Regulatory Focus™ > News Articles > Regulatory Reconnaissance: FDA Effort to Limit Antibiotics Hits Important Milestone (1 July 2014)

Regulatory Reconnaissance: FDA Effort to Limit Antibiotics Hits Important Milestone (1 July 2014)

Posted 01 July 2014 | By Alexander Gaffney, RAC 

Regulatory Reconnaissance: FDA Effort to Limit Antibiotics Hits Important Milestone (1 July 2014)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Your editor is on “vacation” this week. Regulatory Reconnaissance will continue as scheduled, but all other news is on hold until 7 July 2014.

In Focus: US

  • FDA Secures Full Industry Engagement on Antimicrobial Resistance Strategy ( FDA) ( FDA)
  • FDA Releases Strategic Priorities Document ( FDA)
  • As right-to-try landscape expands in U.S., so does debate on laws' effect ( BioCentury)
  • NIH, FDA Launching Workshops on the Development of New Antibacterial Products ( FDA)
  • Generic Relabeling Speed Could Get Supreme Court Review ( Pink Sheet-$) ( Law 360-$)
  • FDA clearance for augmented reality device lets surgeons see each critical step before they make it ( MedCity News)

In Focus: International

  • Tokyo prosecutor to charge Novartis Japan unit, ex-employee over manipulating data ( Reuters)
  • Possible Misconduct In BMS Sprycel Trials, Third Party Investigation To Follow ( PharmAsia-$)
  • EMA clarifies advanced-therapy classification ( BioCentury)
  • Roche rebuts criticism of Tamiflu stockpiling ( FT-$) ( FirstWord Pharma)
  • EMA accepts Merck’s pembrolizumab MAA for review ( Pharma Letter-$) ( PMLive) ( Pharma Times)
  • Indian Pharma Sector’s Regulatory Troubles Lead it to Hire PR Group ( Fierce) ( Why the PR is Needed)
  • India set to hear Sovaldi patent objections case ( SCRIP-$)

US: Pharmaceuticals and Biotechnology

  • FDA Secures Full Industry Engagement on Antimicrobial Resistance Strategy ( FDA) ( FDA)
  • As right-to-try landscape expands in U.S., so does debate on laws' effect ( BioCentury)
  • NIH, FDA Launching Workshops on the Development of New Antibacterial Products ( FDA)
  • Generic Relabeling Speed Could Get Supreme Court Review ( Pink Sheet-$) ( Law 360-$)
  • FDA Re-Opens Comment Period on OTC Monograph System Overhaul ( FDA)
  • FDA Review “Program” Tweaks May Include Smaller Mid-Cycle Meetings ( RPM Report-$)
  • SteriWeb Medical Receives FDA OTC Clearance for Resistance Free Antimicrobial Gel ( Press)
  • Another Federal Court Rejects the ANDA RLD Theory of Liability: The Sixth Circuit Weighs In ( FDA Law Blog)
  • Throckmorton on Abuse Deterrence ( FDA)
  • What You Need to Know to Keep Your Company’s Promotions Out of the Enforcement Spotlight ( PCM)
  • BMS Issues Voluntary Nationwide Recall of COUMADIN for Injection Due to Presence of Particulate Matter ( Press) ( Press)
  • Supreme Court Won't Hear Teva Case Over CAFA Removals ( Law 360-$)
  • Medical Supply Liquidators Injectable Vitamin Products With a "Sunshine Labs" Label: Warning - Products Not FDA Approved ( FDA)

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

  • Vertex Submits sNDA to FDA for Use of KALYDECO in People 18 and Older with Cystic Fibrosis Who Have the R117H Mutation ( Press) ( Press)
  • GlaxoSmithKline, Theravance seek FDA nod for combo once-daily asthma inhaler ( MedCity News) ( Pink Sheet-$) ( Pharma Times)
  • Angling for early OK, Amgen wins 'breakthrough' title for leukemia drug ( Fierce) ( Press)
  • Ipsen files sNDA for Somatuline for GEP-NETs ( Pharma Letter-$) ( Press)
  • Synageva LAL ERT meets Phase III endpoints ( BioCentury)
  • Phase III data support Merck's Emend for children ( SCRIP-$)
  • Specialty Vaccine Company PaxVax Announces Positive Efficacy Results for Phase 3 Cholera Challenge Study ( Press)
  • Salix Announces Statistically Significant Primary Endpoint Result for TARGET 3 Evaluating the Efficacy and Safety of Repeat Treatment with Rifaximin 550mg in Subjects with Irritable Bowel Syndrome with Diarrhea ( Press)
  • Erbitux betters Avastin in bowel cancer subgroup ( PMLive)
  • GlycoMimetics Announces Agreement with FDA on Special Protocol Assessment for Phase 3 Clinical Trial of Rivipansel (GMI-1070) ( Press)

US: Pharmaceuticals and Biotechnology: General

  • Seven reasons birth control pills shouldn't require a prescription ( Vox)
  • Study finds vaccine side effects extremely rare ( USA Today)
  • Sunshine Act exemption for CME payments could shift marketing ( Modern Healthcare)
  • Actavis, Forest To Sell or Relinquish Generics Rights ( WSJ-$) ( Law 360-$) ( Press)
  • New Weapon in Fight Against 'Superbugs' ( WSJ-$)
  • 90 Percent of Drug Companies Still Offer Payment Assistance ( IHP-$)

US: Medical Devices

  • Allergan reveals FDA win, lobbies to keep Valeant out ( Mass Device)
  • FDA clearance for augmented reality device lets surgeons see each critical step before they make it ( MedCity News)
  • Edwards Lifesciences wins FDA nod for ClearSight monitor ( Mass Device)
  • EDAP creeps toward FDA approval with clean inspection ( Mass Device)
  • Medical Devices, the FDA, and the Home Healthcare Clinician ( PubMed)
  • Nephros Announces FDA 510(k) Submission of DSU-H and SSU-H Ultrafilters to be used to filter EPA quality drinking water to remove microbiological contaminants and waterborne pathogens ( Press)
  • 23andMe co-founder Anne Wojcicki’s Washington charm offensive ( WaPo)
  • In obesity device race, ReShape lines up with FDA ( Fierce) ( Press)

US: Dietary Supplements

  • FDA Cedes To Marketplace As Personal Care Sector Enforcer – Attorney ( Tan Sheet-$)
  • Common herbal supplement can cause dangerous interactions ( Press)
  • FTC Accelerates Crackdown on Weight-Loss Claims ( NPI)

US: Assorted And Government

  • FDA Releases Strategic Priorities Document ( FDA)
  • FDA Seeking Access to Longitudinal Patient-Level Electronic Medical Record Data ( FDA)

Europe

  • EMA clarifies advanced-therapy classification ( BioCentury)
  • Roche rebuts criticism of Tamiflu stockpiling ( FT-$) ( FirstWord Pharma)
  • EMA accepts Merck’s pembrolizumab MAA for review ( Pharma Letter-$) ( PMLive) ( Pharma Times)
  • Draft guideline on the clinical investigation of medicinal products to prevent development/slow progression of chronic renal insufficiency ( EMA)
  • Staar Surgical wins CE Mark for pre-loaded Visian ICL ( Mass Device)
  • Expanding Orthopedics Inc. has Obtained CE Mark for its Unique FLXfit, 3D Expandable Interbody Cage ( Press)
  • EDQM Still Against Selling of Organs ( EDQM)

India

  • Indian Pharma Sector’s Regulatory Troubles Lead it to Hire PR Group ( Fierce) ( Why the PR is Needed)
  • India set to hear Sovaldi patent objections case ( SCRIP-$)
  • FICCI asks govt to recast adverse rules of 2013-14 to revive clinical trial industry ( PharmaBiz)

Japan & China

  • Tokyo prosecutor to charge Novartis Japan unit, ex-employee over manipulating data ( Reuters)
  • Possible Misconduct In BMS Sprycel Trials, Third Party Investigation To Follow ( PharmAsia-$)
  • Eisai Files For Approval Of Thyroid Cancer Drug Lenvatinib In Japan ( PharmAsia-$)

Other International

  • Safety the name of the game in evolving Korean device regulatory system ( Clinica-$)
  • Canada Experiencing Shortage of Medical Marijuana ( CBC)

Clinical Trials

  • A University’s Clinical Research Practices Will be Examined ( Pharmalot)

General Regulatory And Interesting Articles

  • Effectiveness of addiction drugs 'depends on phase of addiction' ( MNT)
  • Diabetes drugs 'do more harm than good' for older people ( Pharma Times)

Regulatory Reconnaissance #348 – 1 July 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.

Did we miss a story? Send us a tweet at @RAPSorg and we'll check it out for inclusion in our next edition of Regulatory Reconnaissance. Want this in your inbox each morning? Sign up for RF Today, our morning intelligence newsletter here.

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


Categories: Recon, Regulatory News

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