Regulatory Focus™ > News Articles > Regulatory Recon: The President's Plan to Combat Antibiotic Resistance (27 March 2015)

Regulatory Recon: The President's Plan to Combat Antibiotic Resistance (27 March 2015)

Posted 27 March 2015 | By Alexander Gaffney, RAC

Regulatory Recon: The President's Plan to Combat Antibiotic Resistance (27 March 2015)

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

In Focus: US

In Focus: International

  • EMA recommends approval of Gardasil 9 vaccine, other drugs (Reuters) (EMA) (EMA) (EMA)
  • EU clears German scheme to exempt pharma groups from price freezes (Reuters)
  • EC Approves Medicines Company's Cangrelor (EC)
  • Europe approves Orexigen's weight-loss pill Mysimba (PharmaTimes) (BioCentury)
  • German medtechs fear benefit assessments rule could go too far (Clinica-$)
  • Health Canada Moves Forward With Safety Rules, Limits Disclosure of Trade Secrets (FDAnews-$) (SCRIP RA-$)
  • Two experimental Ebola vaccines pass safety test in African trial (Reuters) (SCRIP-$) (WSJ-$) (NIH) (Bloomberg)

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teamed up with the Combination Products Coalition (CPC) to offer a full day interactive program focused on FDA's newest draft guidance on Good Manufacturing Practices (GMPs) for combination products.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 1 April 2015 program here.

US: Pharmaceuticals and Biotechnology

  • White House unleashing five-year plan to fight superbugs (Reuters) (MedPageToday) (Politico) (Bloomberg) (HHS)
  • Patient understanding of drug risks: an evaluation of medication guide assessments (PubMed)
  • FDA Rejects Biosimilar Citizen Petition (FDA Law Blog) (Law 360-$)
  • Millennium Beats Off-Label Suit, But Free Speech No Factor (Law 360-$)
  • Some Potential Problems in a Priority Review Voucher Reauthorization Bill (FDA Law Blog)
  • The Newest Twist in the State Regulation of Off-Label Marketing (Harvard BOH)
  • BioChemics, Inc. Pays the SEC $17.9 Million For Allegedly Misrepresenting FDA Review and Drug Trial Status To Investors (Policy and Medicine)
  • Pleasantries aside, U.S. FDA keeps sharp eye on India pharma manufacturing (Reuters)
  • Sandoz’s Biosimilar Launch Eyed For May 11 Or Earlier, Absent Court Injunction (Pink Sheet-$)
  • Reopening The LABA Class: FDA Shepherds Breo Through Committee For Asthma (RPM Report-$)

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

  • Novo to resubmit Tresiba and Ryzodeg in the US (PharmaTimes) (Reuters)
  • Ohr Pharma's eye drug fails main goal in mid-stage study (Reuters)
  • Conatus heralds success for its NASH drug and plots Phase III (Fierce)
  • Genfit's NASH drug flunks Phase II, but management sees a silver lining (Fierce) (Reuters)

US: Pharmaceuticals and Biotechnology: General

  • Whitfield, Kennedy, Bucshon, and Pallone Introduce Legislation to Combat Prescription Drug Abuse (House)
  • Kentucky bans sale of DXM to minors (DSN)
  • House Committee Hears Testimony on Drug Abuse (E&C)
  • Foster care kids put on too many psych drugs, report says (CBS)

US: Medical Devices

  • Endoscope maker Olympus revises cleaning instructions (Modern Healthcare) (Reuters) (FDA) (FDA) (Washington Post) (MDDI)
  • FDA Approving Devices Faster (MDDI)
  • FDA, FCC Holding a Joint Workshop on Promoting Medical Technology Innovation Next Week (FCC)
  • Tips for Device Makers Facing the UDI System (MDDI)
  • FDA Reclassifying Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aids into Class II (FDA)
  • Stryker gets FDA clearance to use Mako robot for hip replacement (Fierce)
  • TraumaCAD Mobile Hip Replacement Planning for iPad Scores FDA Clearance (MedGadget)

US: Dietary Supplements

  • Sen. Harry Reid to Retire in 2016. Could Dick Durbin Become the Ranking Senate Democrat? (NYTimes)

US: Assorted And Government

  • FDA Enforcement Report - Week of March 25, 2015 (FDA)

Upcoming Meetings and Events

Ebola Outbreak

Europe

  • EMA recommends approval of Gardasil 9 vaccine, other drugs (Reuters) (EMA) (EMA) (EMA)
  • EU clears German scheme to exempt pharma groups from price freezes (Reuters)
  • EC Approves Medicines Company's Cangrelor (EC)
  • Europe approves Orexigen's weight-loss pill Mysimba (PharmaTimes) (BioCentury)
  • German medtechs fear benefit assessments rule could go too far (Clinica-$)
  • Unannounced Inspections by Notified Bodies a 'Principal Challenge' for 2015 (MedDeviceSummit)
  • Paediatric addendum to the note for guidance on the clinical investigation on medicinal products in the treatment of hypertension (EMA)
  • Guideline on clinical investigation of medicinal products for the treatment of systemic lupus  erythematosus and lupus nephritis (EMA)
  • Guideline on core SmPC for human normal immunoglobulin for subcutaneous and intramuscular administration (EMA)
  • Global health changes and overcoming regulatory challenges was a major part of the MHRA Annual Lecture (MHRA)
  • EMA Validates Biogen's Marketing Authorisation Application for ZINBRYTA (Daclizumab High-Yield Process) for Treatment of MS (Press)

India

  • Govt soon to roll out materio-vigilance programme to ensure safety of medical devices at point of care (PharmaBiz)

Japan

  • East vs West: how Japan’s new auditing system differs from the EU (Clinica-$)

Canada

  • Federal Justice Department part of CanadaDrugs.com raid (CBC)
  • Health Canada Moves Forward With Safety Rules, Limits Disclosure of Trade Secrets (FDAnews-$) (SCRIP RA-$)

Clinical Trials

  • SACHRP Contends NIH Single IRB Mandate Is ‘Premature’ (Thompson's)
  • Living With Cancer: Clinical Trials Looking for Patients (NYTimes)

General Regulatory And Interesting Articles

  • New pandemic insurance to prevent crises through early payouts (Reuters)

Regulatory Reconnaissance #523 – 27 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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