Regulatory Focus™ > News Articles > Regulatory Recon: FDA to Place Additional Inspectors in China (24 November 2014)

Regulatory Recon: FDA to Place Additional Inspectors in China (24 November 2014)

Posted 24 November 2014 | By Alexander Gaffney, RAC

Regulatory Recon: FDA to Place Additional Inspectors in China (24 November 2014)

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

In Focus: US

  • FDA Puts Inspection Agreement With China in Place (FDA) (In-Pharma)
  • Tufts study: it takes eight drugs in clinical trials to get one approval ​ (BioFlash)
  • Is Stockpiling Protected By Hatch-Waxman Safe Harbor? (Law 360-$)
  • FDA launches 'Snapshot' subgroup data website  (SCRIP-$) (FDA) (FDA)
  • CDER Has 650 Unfilled Positions, Woodcock Says (BioCentury)
  • Congress ponders health IT regs and the FDA, again (Modern Healthcare)
  • Device Cos. Want Separate Twitter Guidance From FDA (Law 360-$)
  • Packaging, software issues account for 40% of medical device recalls, report finds (Fierce)

In Focus: International

  • Testosterone Drugs may – or may not – Cause Heart Risk: EMA (Pharmalot) (Fierce) (EMA)
  • Guideline on the use of phthalates as excipients in human medicinal products (EMA)
  • India plans to bring all pharma related departments under one roof (India Times) (PharmaBiz)
  • Ban on plastic bottles may hike drug prices (India Times)
  • Canadian drug recalls triple in less than 10 years (National Post)
  • Nigerian Regulators on Strike (AllAfrica)
  • Gates Foundation Says All Data From Trials it Supports Must be Made Public (Gates)

US: Pharmaceuticals and Biotechnology

  • FDA Puts Inspection Agreement With China in Place (FDA) (In-Pharma)
  • Tufts study: it takes eight drugs in clinical trials to get one approval ​ (BioFlash)
  • Is Stockpiling Protected By Hatch-Waxman Safe Harbor? (Law 360-$)
  • FDA launches 'Snapshot' subgroup data website  (SCRIP-$) (FDA) (FDA)
  • CDER Has 650 Unfilled Positions, Woodcock Says (BioCentury)
  • Woodcock: Breakthrough designation mostly about efficacy (BioCentury) (PharmExec)
  • When To End A REMS? Soliris Review Stirs Debate On How To Scale Back (Pink Sheet-$)
  • Concerta Generics Suit Could Illuminate FDA Bioequivalence Decision-making (Pink Sheet-$)
  • FDA workshop on therapies for rare patient subsets (BioCentury)
  • Aurobindo Pharma USA, Inc. Issues Voluntary Nationwide Recall of Northstar Label Gabapentin Capsules, USP 300 mg Due to Complaints of Empty Capsules (Press)
  • Transparency Window Shuts Further At OGD – Hopefully Only Temporarily (Lachman)
  • Off-Label Corticosteroid Use Could Get Contraindication From FDA (Pink Sheet-$)
  • BioMarin buys Prosensa for up to $840M, shoots for quick OK of Duchenne drug (Fierce)
  • More on the DSCSA Requirements Coming Into Effect in January 2015 (RxTrace)
  • Perrigo Confirms First to File Patent Challenge for Generic Version of Aveed (Testosterone Undecanoate) Injection (Press)
  • Mislabeling Leads to Recall of Highly Concentrated Potassium Chloride (MPR) (FDA)
  • Jaguar Animal Health Appoints Former Merial Executive to Head Regulatory Affairs (Press)

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

  • CAR-T player Juno picks up 'breakthrough' status for lead cancer therapy (Fierce)
  • Avaxia Biologics Receives FDA Orphan Drug Designation for AVX-470 for the Treatment of Pediatric Ulcerative Colitis (Press)
  • FDA Grants Orphan Drug Status For Immunomedics' Veltuzumab To Treat Pemphigus (Press)
  • Insys Therapeutics Receives FDA Orphan Drug Designation for Its Pharmaceutical Cannabidiol as a Potential Treatment for Pediatric Schizophrenia (Press)
  • Catabasis Pharmaceuticals Receives FDA Orphan Drug Designation for CAT-1004 for the Treatment of Duchenne Muscular Dystrophy (Press)
  • Positive Ph III results for Relypsa’s patiromer FOS for hyperkalemia (Pharma Letter-$)
  • Encouraging Results For Two New Drugs That Fight A Common And Dangerous Side Effect (Forbes)
  • Two drugs found effective in treating excess potassium (Reuters)

US: Pharmaceuticals and Biotechnology: General

  • U.S. Rx Drug Spending To Increase Nearly 12% This Year (CA Healthline)
  • Vaccine Injury Compensation: Most Claims Took Multiple Years and Many Were Settled through Negotiation (GAO)
  • Private Oncologists Being Forced Out by High Drug Prices (NYTimes)
  • High Cost of New Drugs Weighs on Medicaid (Arkansas Business)

US: Medical Devices

  • Congress ponders health IT regs and the FDA, again (Modern Healthcare)
  • Device Cos. Want Separate Twitter Guidance From FDA (Law 360-$)
  • Local Coverage With Evidence Development Is Legit, CMS Says In Final Guidance (Gray Sheet-$) (BioCentury)
  • Packaging, software issues account for 40% of medical device recalls, report finds (Fierce)
  • Transvaginal mesh trial losses put pressure on Boston Scientific (Reuters)
  • A Medical Device Is Sidelined, but Too Late for One Woman (WSJ-$)
  • Power Morcellator Lawsuits Ramp Up (Press)
  • Woman dies after metal detector causes pacemaker to malfunction (Fox)

US: Dietary Supplements

  • NAD recommends company remove "survival pill" claims for product marketed to Mormons (NI-USA)
  • FDA Warning On Gerber Formula Claims Strikes Familiar Chord With FTC Complaint (Tan Sheet-$)

US: Assorted And Government

  • Rep. Upton updates 21st Century Cures timeline (BioCentury) (IHP-$)
  • Bipartisan bill would expand veterans' access to medical marijuana (The Hill)

Upcoming Meetings

Ebola Outbreak

  • Cerus Corporation (CERS) Gets FDA Green Signal For Ebola Blood Transfusion Device (Bidness)
  • Merck steps into Ebola vaccine race with NewLink rights deal (Fierce) (Press) (Bloomberg)
  • Bandits in Guinea Steal Suspected Ebola Blood (AP)

Europe

  • Testosterone Drugs may – or may not – Cause Heart Risk: EMA (Pharmalot) (Fierce) (EMA)
  • Guideline on the use of phthalates as excipients in human medicinal products (EMA)
  • EU approves Novartis' Signifor drug for rare hormonal disorder (Reuters)
  • AstraZeneca COPD drug combination approved in EU (PharmaPhorum) (Press)
  • UK Hospitals to play part in Gov efforts to speed clinical trial process (Outsourcing Pharma)
  • Pricing key after EU blesses AbbVie hep C breakthroughs (SCRIP-$)
  • Covidien wins home-use CE Mark for Nellcor oxygen monitor (Mass Device)
  • J&J racks up another diabetes no from Germany's IQWiG (SCRIP-$)

India

  • Government plans to bring all pharma related departments under one roof (India Times) (PharmaBiz)
  • Ban on plastic bottles may hike drug prices (India Times)
  • India’s Price Watchdog Mulls Price Caps On Selected Oncology Drugs (PharmAsia-$)
  • India Revokes Licenses of Two Drugmakers Linked to Sterilization Deaths (PharmaBiz)
  • Insight On India – Highlights From The Week Of Nov 16-22, 2014 (Two-Four Insight)
  • Observations On Modi’s Impact On The Life Sciences Industry In India (Two-Four Insight)

Japan

  • Janssen/Gilead HIV combo among Japanese approvals (SCRIP-$)
  • ZOLL Files with Japan’s Pharmaceuticals and Medical Devices Agency for New Indication for Intravascular Temperature Management Technology (Press)
  • Merck Submits New Drug Application to the Japanese Pharmaceuticals and Medical Devices Agency for Omarigliptin, an Investigational Once-Weekly DPP-4 Inhibitor for Type 2 Diabetes (Press)

Canada

  • Prescription drug recalls triple in less than 10 years (National Post)
  • Vancouver Experiments With Prescription Heroin (The Atlantic)

Australia

  • ARIAD and STA Announce Approval of Iclusig (Ponatinib) in Australia (Press)
  • Recall for Two Devices in Australia (TGA) (TGA)

Other International

  • Presentations at 19th AHWP Annual Meeting (AHWP)
  • Nigerian Regulators on Strike (AllAfrica)

Clinical Trials

  • Gates Foundation Says All Data From Trials it Supports Must be Made Public (Gates)
  • CROs mostly positive on proposed rule to make clinical trials more transparent (Outsourcing Pharma)

General Regulatory And Interesting Articles

  • Anesthesia Miracle: No Power, No Oxygen Tanks, No Problem (NPR)
  • The Insanity of Vintage Drug Ads (SuperCompressor)

Regulatory Reconnaissance #447 – 24 November 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.

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

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe