Regulatory Focus™ > News Articles > Regulatory Recon: FDA Struggles With ANDA Backlog; Trump Calls for Reimportation of Cheap Drugs (3 M

Regulatory Recon: FDA Struggles With ANDA Backlog Trump Calls for Reimportation of Cheap Drugs (3 March 2016)

Posted 03 March 2016 | By Zachary Brennan 

Regulatory Recon: FDA Struggles With ANDA Backlog Trump Calls for Reimportation of Cheap Drugs (3 March 2016)

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

In Focus: US

  • GAO Issues Report on Pediatric Voucher Program, Findings Inconclusive (FDA Law Blog) (In the Pipeline) (Focus)
  • FDA Still Struggling with Backlog of Generic Drug Applications (STAT)
  • Califf sets out his top priorities for drug and device safety (BioWorld-$) (SCRIP-$) (InsideHealthPolicy-$)
  • Insurers Probed on Hepatitis C Drug Coverage (WSJ-$)
  • Trump Plan Would Allow Reimportation of Cheaper Drugs (STAT) (Huffington Post) (Plan)
  • GOP Congressmen Question The Need For $2 Billion To Fight Zika Virus (NPR) (Focus)

In Focus: International

  • India to station drug inspection team in China (PharmaBiz)
  • IGBA calls for full transparency and new timelines for impact assessment with regard to the voluntary WHO biological qualifier (BQ) proposal (IGBA)
  • UK pharmaceutical market set to grow to $43 billion by 2020; Report (PharmaLetter-$)
  • Rodent carcinogenicity testing: ICH plans changes to guidance (Focus)

US: Pharmaceuticals and Biotechnology

  • Biologic and Biosimilar Drugs—How Federal and State Policy Will Affect Their Use (Pew)
  • Juno and Kite fight it out to be first to market (EP Vantage)
  • Alaska’s Biotech Sugar Daddy Is Showering Money on Startups (Bloomberg News)
  • Spurned in Duchenne, BioMarin Will Seek Approval For Batten Drug (Xconomy) (TheStreet)
  • East Coast Biotech Roundup: Ribon, Syndax, Aldeyra & More (Xconomy)
  • New method of drug delivery may be safer and more effective against pancreatic cancer (Manufacturing Chemist)
  • GSK Asks High Court To Nix Avandia RICO Class Suit (Law360-$)
  • Promotion of Investigational Compound – Historical Overview (EyeonFDA)
  • Animated drug ads prompt FDA study into effect on consumer behavior (STAT) (BioPharmaDive)
  • Leading Alzheimer’s group splinters over claims of misplaced priorities, lavish spending (STAT)
  • Valeant comments on management change (PR)
  • Launch of the First precisionFDA Consistency Challenge on DNAnexus-Built Cloud-Based Community Platform (PR)
  • Premier and Oncobiologics Align to Advance Adoption of Biosimilar Drugs (PR)

Clinical Study Results, Filings and Designations

  • Merck, Pfizer and Verastem Announce Combination Trial of Avelumab and VS-6063 in Ovarian Cancer (PR) (GEN)
  • Express Scripts Says Novo Insulin Data Not Convincing Enough (Bloomberg News)
  • Centauri, Horizon form immuno-oncology JV (PharmaTimes)
  • Advanced Immunotherapeutic Method Shows Promise against Brain Cancer (GEN)
  • Scientists still fail to record age and sex of lab mice (Nature News)
  • Fat mice provide clue to obesity-colon cancer puzzle (Nature News)
  • The Genetics of Dyslipidemia — When Less Is More (NEJM)
  • Data too important to share: do those who control the data control the message? (BMJ)
  • Evolving Approaches in Research and Care for Ovarian Cancers (JAMA)
  • Brain Trust: Cutting-Edge Treatments for Glioblastoma on the Rise (Cure Today)
  • Toward a complete genetic picture of heart disease (Broad Institute)

US: Medical Devices

  • Recent US FDA regulatory updates you should know about (MassDevice)
  • FDA approves Medtronic’s Specify SureScan MRI-safe neurostim leads (MassDevice)
  • Sunshine Heart halts trial, ousts CEO Rosa (MassDevice)
  • Virtual Incision’s inside-the-body surgical robot logs 1st-in-human use (MassDevice)
  • Apple Watch study aims to enroll 40,000 to uncover mysteries of how we sleep (Washington Post)
  • Reclassification of blood lancets (Federal Register)
  • Unplanned pregnancies are at a 35-year low — and IUDs are mostly to thank (Vox)

US: Assorted and Government

  • US Regulators Permit Kannalife Sciences to Import Cannabidiol for Feasibility Studies (BioPharm International)
  • State sets new limits on opioid prescriptions (Mass Recorder)
  • Form 483 for Florida Compounder (FDA)
  • Biomarkers for Brain Injury Monitoring (FDA)
  • Senate Dems offer rival bill on GMO food labels (The Hill)

Upcoming Meetings and Events              

Europe

  • Baxter files its long-acting haemophilia A therapy in Europe (PharmaTimes) (PharmaLetter-$)
  • Merck and the European Molecular Biology Laboratory agree three-year drug discovery collaboration (Manufacturing Chemist) (PharmaTimes)
  • NIHR links with Novartis for Xolair study (PharmaTimes)
  • BMA warns of growing crisis in general practice (PharmaTimes)
  • Public consultation on preliminary opinion on biological effects of ultraviolet radiation (European Commission)
  • Medicines: licensing time-based performance measures (MHRA)
  • UK government rejects calls for meningitis B vaccine for all children (PharmaPhorum)
  • MorphoSys to boost R&D budget by 40% as clinical trials ramp up (Fierce)

India

  • Devices sector upset as no support in budget & regulatory matters from the govt (PharmaBiz)
  • SUGAM online services initiated by CDSCO (Notice) (PharmaBiz)

Canada

  • Rexall takeover shakes up Canada's drugstore industry (Globe and Mail)

Zika Virus

  • Mosquitoes don’t bug tourists on Brando’s island. Here’s why that matters (STAT)
  • Subcommittee on Oversight Examines US Preparedness for Zika (PR)
  • Vaxart Begins Preclinical Testing of an Oral Zika Virus Vaccine (PR)

Other International

  • WHO Regional Director calls for urgent funding to support Syria health response (WHO)

General Health and Other Interesting Articles

  • Happiness can break your heart (STAT)
  • Neurostimulation: Bright sparks (Nature)
  • Health care takes on the fight against trafficking (Marketplace)
  • Science is too secretive and slow. So this researcher is live-blogging her work. (Vox)
  • Stop needless dispute of science in the courts (Nature News)
  • Probiotics Are Common in Hospitals, but Evidence Is Lacking (NY Times)
  • Uterine transplant raises hopes and ethical questions (STAT)

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 @Michael_Mezher 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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