Regulatory Focus™ > News Articles > Regulatory Recon: FDA Seeks Budget Increase (3 February 2015)

Regulatory Recon: FDA Seeks Budget Increase (3 February 2015)

Posted 03 February 2015 | By Alexander Gaffney, RAC

Regulatory Recon: FDA Seeks Budget Increase (3 February 2015)

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

In Focus: US

In Focus: International

  • Amid new drug negotiations, China puts price-management vet in charge of CFDA (Fierce)
  • A Closer Look At China’s Drug Lag Promises (PharmAsia-$)
  • Novartis faces suspension in Japan after series of trial data scandals (Fierce) (Japan Times)
  • Obama Effect! India Pressured On Data Exclusivity, Patent Linkage? (PharmAsia-$)
  • Gathering pace: adaptive pathways in the EU (PMLive)
  • Ireland Threatens Legislation to Force Drug Makers to Lower Prices (Pharmalot)

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US: Pharmaceuticals and Biotechnology

  • FDA System for Reporting Side Effects Needs a ‘Thorough Overhaul:’ Study (Pharmalot) (NYTimes)
  • Biologics Marketing Exclusivity Threatens TPP Trade Agreement (Biopharm International) (Reuters) (Politico)
  • Lost in translation: USFDA inspectors, Indian drugmakers face language gap (India Times)
  • FDA Reopens Debate Over Contentious Generic Drug Labeling Rule (IHP-$)
  • Interchangeable Biosimilar Applications Coming In FY 2015, FDA Expects (Pink Sheet-$)
  • User Fees Would Recede In Significance Under President’s Budget (Pink Sheet-$)
  • Lilly and Boehringer win FDA approval for a combo diabetes drug (Fierce) (PharmaTimes) (SCRIP-$) (Pharmafile)
  • Background Analysis: US FDA Advisory Committee to Review Kythera’s Deoxycholic Acid Injection for Reducing Chin Fat (Tarius)
  • Lawmakers to Probe Flu Vaccine Production Process (WSJ-$)
  • Virginia Advances "Right to Try" law (Scout)
  • Facing a long wait for evidence, a longevity researcher takes an unusual path to market. (MIT TR)
  • FDA’s Social Media Oversight: An Ounce of “Cure” is Worth a Pound of Enforcement (Strasburger)
  • DEA Scheduling Reform Bill to be Marked up in Congress (E&C)
  • Rulemaking Needed For Acetaminophen Label Warning – CHPA (Tan Sheet-$)
  • FDA’s First Action under the Sunscreen Innovation Act  (Registrar Corp)
  • Biosimilars need a shorter road to approval, study argues (ModernHealthcare-$)
  • Dr. Reddy's mulling facility shift to avoid losing out on Nexium generic (Fierce)
  • Flexible Dosing Option for Hizentra Approved (MPR)

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

  • Esperion gets out from under the FDA and speeds toward Phase III (Fierce)
  • Isis Pharma's diabetes drug successful in mid-stage study (Reuters) (Counter: The Street)
  • AstraZeneca partner Ardelyx plunges after citing safety issue for lead drug (Fierce) (PharmaTimes)
  • U.S. FDA Grants Priority Review to YONDELIS NDA for Advanced Soft-tissue Sarcoma (Press)

US: Pharmaceuticals and Biotechnology: General

  • HHS wants power to negotiate specialty drug prices (CNBC) (NYTimes) (AP) (Reuters)
  • Decline In Economic Returns From New Drugs Raises Questions About Sustaining Innovations (HealthAffairs)
  • Hospira Primer on Biosimilars (YouTube)
  • There's an effective medicine for heroin addiction, but anti-drug warriors are fighting it (Vox)
  • Merck Launches New Insomnia Drug Belsomra (Press)

US: Medical Devices

  • FDA clears 3-D printed device for minimally invasive foot surgery (Fierce)
  • FDA okays 2 new algorithms for AliveCor's ECG app (MassDevice)
  • PARI Snags FDA Approval for eRapid Powered Nebulizer System (MedGadget)
  • MQSA National Statistics (FDA)
  • Guided Therapeutics Provides an Update on FDA Review Time for LuViva® Advanced Cervical Scan (Press)

US: Dietary Supplements

  • New York Attorney General Targets Supplements at Major Retailers (NYTimes) (NYTimes) (AP)
  • Food Safety Modernization Act Tied to FDA’s Budget Request for More Money (FPD)

US: Assorted And Government

  • FDA Asks Congress for $4.9 Billion Budget in 2016, a 9% Increase (FDA) (FDA) (Strengthen FDA) (In-Pharma) (BioCentury) (SCRIP-$)
  • Why Duke's Robert Califf could meet high expectations as FDA deputy commissioner (BioCentury-$)
  • Why Duke's Califf does not have to succeed Hamburg to shape FDA policy (BioCentury-$)
  • What Does Nissen Think Of Califf’s Move To FDA? (RPM Report-$)
  • Physician Payments Sunshine Act: Year 2 of Data Submission Begins Today (Policy and Medicine)
  • New FDA Guidances for January 2015 (Cato)

Upcoming Meetings

Ebola Outbreak

Europe

  • Gathering pace: adaptive pathways (PMLive)
  • Heartburn drug esomeprazole is first proton pump inhibitor to be sold outside pharmacies in the UK (PharmJournal-$)
  • Ireland Threatens Legislation to Force Drug Makers to Lower Prices (Pharmalot)
  • U.K. set to kick off huge genome project with U.S. right behind (Fierce)
  • Britain Set To Vote On '3-Parent Baby' Law Tuesday (NPR)

India

  • Obama Effect! India Pressured On Data Exclusivity, Patent Linkage? (PharmAsia-$)
  • More AMCs to be identified for access to WHO database through Vigiflow software as part of PvPI (PharmaBiz)

China

  • Amid new drug negotiations, China puts price-management vet in charge of CFDA (Fierce)
  • A Closer Look At China’s Drug Lag Promises (PharmAsia-$)
  • Chinese square off against Alibaba in palace intrigue as online drug sales loom (Fierce)

Japan

  • Novartis faces suspension in Japan after series of trial data scandals (Fierce) (Japan Times)
  • Japan Pushes Advanced Trials for Personalized Medicines (FDAnews-$)

Canada

  • Health Canada continues to identify unlicensed home test kits being sold to Canadians (Health Canada)

Clinical Trials

  • Case Study – Applying the FAIR Shake (iMarc)

General Regulatory And Interesting Articles

  • Should you be able to sue a parent for not vaccinating their child? (Today)
  • Two common drugs could be deadly combination for seniors (CBS)

Regulatory Reconnaissance #485 – 3 February 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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