Regulatory Focus™ > News Articles > Regulatory Recon: FDA, Industry Reach Agreement on GDUFA II; CFDA Proposes Priority Review Pathway f

Regulatory Recon: FDA, Industry Reach Agreement on GDUFA II CFDA Proposes Priority Review Pathway for Devices (1 September 2016)

Posted 01 September 2016 | By Michael Mezher 

Regulatory Recon: FDA, Industry Reach Agreement on GDUFA II CFDA Proposes Priority Review Pathway for Devices (1 September 2016)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher, @Zachary Brennan and @RAPSorg on Twitter

In Focus: US

  • FDA Begins Process of Overhauling Off-Label Communications Regulations (Focus)
  • The dark side of 'compassionate use' of experimental drugs (Washington Post)
  • Roche's new-drug strategy buoyed by lung-cancer study (Reuters) (Pharmafile) (Press)
  • Biogen's Plaque-Busting Alzheimer's Drug Shows Promise (MIT Technology Review) (Fierce) (Press)
  • A Cure for Swelling Drug Prices: Competition (WSJ)
  • Monopolies On Medical Knowledge And Information Are Unethical (Forbes)
  • GDUFA II Will Include Small Business Relief, Priority ANDA Reviews (Pink Sheet-$) (DSN) (GPhA) (PBOA)
  • FDA Calls for Boxed Warning on Two Drug Classes (Focus)
  • Citizen Petitions: Long, Late-Filed, and At-Last Denied (SSRN)
  • How EpiPen's Price Rose and Rose (Bloomberg)
  • Senators Question Mylan CEO Over EpiPen Pricing, Generic Plans (Focus)
  • Mylan's Generic EpiPen — A Price Break Or Marketing Maneuver? (KHN)
  • A day of soul-searching for CAR-T bulls (EP Vantage)
  • Red tape at the FDA doesn't explain America's high drug prices (Vox)
  • From AIDS to Opioids — How to Combat an Epidemic (NEJM)
  • The Primary Outcome Fails — What Next? (NEJM)
  • Access to Essential Medicines in the United States (NEJM)
  • What do patients know about generic biotech drugs? (Reuters)
  • Waiting for Cancer (NYTimes)
  • Billions Of Dollars Of Vaccines Have Gone To Waste (Forbes)
  • DC Circ. Ruling Dangerous For Hatch-Waxman: Takeda (Law360-$)
  • NIH review finds nondrug approaches effective for treatment of common pain conditions (NIH)

In Focus: International

  • Nestle to buy medical device company Phagenesis in stages (Reuters)
  • Study finds strong link between Zika and Guillain-Barre (Reuters)
  • The Q3D Training Modules 8 to 9 available now on the ICH Website (ICH)
  • CFDA Proposes Priority Review Pathway for Certain "Breakthrough" Medical Devices (National Law Review) (Inside Medical Devices)
  • CFDA clarifies penalties for clinical trial inspections (BioCentury)
  • The Developing World Needs A Cancer Moonshot (Forbes)
  • Takeda begins real-world Multiple Myeloma study (BioCentury)
  • Novo's Chief to Retire, Veteran Joergensen to Succeed Him (Bloomberg) (Reuters)
  • Indian government moves to tackle substandard drugs (PharmaLetter-$)
  • Out-of-spec assay drove Teva to recall antibiotic from Canadian plant (InPharmaTechnologist)

US: Pharmaceuticals & Biotechnology

  • Sunovion pays more than double the market value for a Canadian biotech (Boston Biz Journal)
  • With FDA filing, Mitsubishi Tanabe aims to bring ALS med edavarone to U.S. next year (Fierce)
  • He may have invented one of neuroscience's biggest advances. But you've never heard of him (STAT)
  • Roger Tsien, 1952-2016: "I've always been attracted to colors" (Endpoints)
  • New Technique Improves Analysis of Mitochondrial Dysfunction (GEN)
  • Diabetes Trials Could Include Hypoglycemia As Patient-Reported Outcome (Pink Sheet-$)
  • Investment in Biotechnology Companies -- Nature Biotechnology Report (Patent Docs)
  • Boehringer Ingelheim expands partnership to study rare disease in real-world setting (OutsourcingPharma) (Press)
  • Gilead faces another bid for hep C royalties as U of MN sues for patent infringement (Fierce)
  • Sterility Assurance and Cross Contamination (FDAZilla)
  • Eli Lilly elects Jamere Jackson to board of directors (Pharmafile)
  • Flexible molecules could be better drugs - for some targets (InPharmaTechnologist)
  • Medicines Company investors get ahead of the news (EP Vantage)
  • Communicating about Chemo Side Effects: Clin Onc News Report (Medpage)
  • Agency Information Collection Activities; Proposals, Submissions, and Approvals: Abbreviated New Animal Drug Applications (FDA)

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

  • GenSight Biologics receives Orphan Drug Designation and Advanced Therapy Medicinal Product classification in Europe for GS030 in Retinitis Pigmentosa (Press)
  • Valneva writes off hospital-acquired infection vaccine following PhII/III miss (Fierce)
  • Phase III Study Showed Genentech's Cancer Immunotherapy TECENTRIQ™ (Atezolizumab) Helped People with a Specific Type of Lung Cancer Live Significantly Longer Compared to Chemotherapy (Press)
  • Kamada and Kedrion Seek FDA Approval of Human Rabies Immunoglobulin as a Post-Exposure Treatment (Press)
  • Array BioPharma Announces FDA Acceptance of Binimetinib NDA for Patients with Advanced NRAS-Mutant Melanoma (Press)
  • FDA Approves New AGGRASTAT® Product Format (Press)
  • Perrigo Announces Tentative FDA Approval For Generic Version Of Epiduo® Gel (Press)

US: Medical Devices

  • FDA Uses Summer to Issue Numerous Device Guidance Documents (National Law Review)
  • FDA approves Medtronic's Enlite continuous glucose sensor (MassDevice)
  • Medtronic Asks 9th Circ. To Flip $15M Loss In Device Trial (Law360-$)
  • Theranos Makes Another Unforced Error (MIT Technology Review)
  • September 2016- plan to safeguard imaging facilities (MITA)
  • Ignyta CDx Receives FDA Investigational Device Exemption (GenomeWeb)
  • Brain-Zapping Gadgets Need Regulation, Say Scientists and (Some) Manufacturers (IEEE Spectrum)
  • Few people of color in 'artificial pancreas' tests (Reuters)
  • Alere says Abbott suffering from buyer's remorse over deal (Crain's)

US: Assorted & Government

  • Insurers Move to Limit Options in Health-Care Exchange Plans (WSJ)
  • HHS Awards $53 Million to Fight Opioid Abuse Epidemic (Medpage)
  • Judge blocks FDA's move to shutter Amniotic Therapies (MassDevice)
  • Allergan, Adamas settle patent lawsuit with Amneal (Reuters)
  • PHYSICIAN-ADMINISTERED DRUGS: Comparison of Payer Payment Methodologies (GAO)
  • MEDICARE: 2016 Payment Rates for Complex Wheelchair Accessories (GAO)
  • HeartWare Says Investor Suit Over FDA Regs Is 'Opportunistic' (Law360-$)
  • MDL Court Says "You Don't Belong Here" to Plaintiff "Added by Amendment" (Drug and Device Law)
  • FTC Muscles in on Health Privacy (Genomics Law Report)
  • Parexel delays 10-K filing as it looks into 'misappropriation of corporate funds' (Fierce) (OutsourcingPharma)
  • FDA Finalizes Regulations for Voluntary GRAS Notifications; Few Surprises (FDA Law Blog)

Upcoming Meetings & Events


  • Roche set to re-join the ABPI (ABPI)
  • EU approval for Pfizer's non-small cell lung cancer drug (EPR)
  • Richard Bergström announces his departure from EFPIA after five successful years (EFPIA)
  • Swedish hospital behind Nobel prize criticised over medical scandal (MassDevice)
  • BioTelemetry CE Mark for Holter analysis software (MassDevice)



  • Australia Targets Patient Safety In Cell And Tissue Regulation Overhaul (Pink Sheet-$)
  • Hazard Alerit - HeartWare Ventricular Assist Device (TGA)


  • Malaysia confirms its first Zika case as Singapore's total cases rise to 115 (CNBC)
  • China steps up arrivals checks from Singapore amid Zika outbreak (Reuters)
  • China says 21 of its nationals in Singapore infected with Zika (Reuters)
  • Six Bangladeshi nationals in Singapore infected with Zika (Reuters)
  • Singapore raises Zika tally; first pregnant woman diagnosed (Reuters)

Other International

  • Second meeting of the Emergency Committee under the International Health Regulations (2005) concerning yellow fever (WHO)

General Health & Other Interesting Articles

  • Psoriasis may carry clogged-arteries risk similar to that with diabetes (Reuters)
  • Serious Infections Skyrocket In People Who Inject Illegal Drugs (Forbes)
  • Drop In Teen Pregnancies Is Due To More Contraceptives, Not Less Sex (NPR)

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

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.

Categories: Recon, Regulatory News

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