Regulatory Focus™ > News Articles > Regulatory Reconnaissance: China Seeks UDI System by End of 2014 (24 March 2014)

Regulatory Reconnaissance: China Seeks UDI System by End of 2014 (24 March 2014)

Posted 24 March 2014 | By Alexander Gaffney, RAC

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Read anything we might be interested in sharing? Let us know: news@raps.org.

Do you work in regulatory affairs? Take RAPS' Scope of Practice & Compensation Survey of the Regulatory Profession, a survey of professionals around the world who are involved with the regulatory process for healthcare products. It's the largest, most comprehensive study of the regulatory profession, and helps regulatory professionals benchmark their salary and compensation packages. All survey participants receive a free adanced copy of the report. (More)

In Focus: US

In Focus: International

  • China Hopes To Implement Unique Device Identifier System By Year End (Gray Sheet-$)
  • NICE to rethink valuations of drugs for NHS (FT-$)
  • Proposed EU Law Would Require More Drug-Trial Transparency (WSJ-$) (Pharmafile)
  • MHRA literally shreds clinical trial info after 15 years (All Trials) (Sunday Times)
  • East African Community (EAC) validates technical documents for joint registration and evaluation of medicines (PharmAfrica)
  • Brazil's Cristalia gains ANVISA approval for production of biosimilar drugs (Pharma Letter-$)

US: Pharmaceuticals/Biotechnology

  • Crowdsourcing medical decisions: Ethicists worry compassionate use cases may set bad precedent (Washington Post)
  • Priority Review Vouchers For Pediatric Rare Disease: Will Popularity Force A Quick Halt? (Pink Sheet-$)
  • J&J Ruling Removes FDA Warning Letterss From Plaintiff Playbook (Law 360-$) (D&D Law)
  • FDA OK's Xolair in chronic idiopathic urticaria (SCRIP-$) (Press) (Pharma Letter-$) (MedPage Today)
  • Celgene gets FDA OK for first oral psoriatic arthritis drug (PMLive) (Pharma Letter-$) (SCRIP-$) (FDA) (MedPage Today) (Reuters) (Xconomy) (Press) (BioCentury) (Fierce) (Pink Sheet-$) (Pharma Times) (Bloomberg)
  • Generic Labeling Reg Alternatives Put FDA, Not Firms, In Driver's Seat (Pink Sheet-$)
  • FDA agrees to let patients get controversial drug (USA Today) (Science-Based Medicine)
  • OTC Monograph Process Not Broken But Needs Repair - CHPA (Tan Sheet-$)
  • Why Can't the FDA Fix Outdated Birth Control Labels? (The Daily Beast)
  • Perrigo Sues FDA Over Failure to Grant Therapeutic Equivalence Rating for Testosterone Gel 505(b)(2) NDA (FDA Law Blog)
  • Evidence and Extrapolation: Mechanisms for Regulating Off-Label Uses of Drugs and Devices (SSRN)
  • AHA wants FDA to address IV fluids shortage (Modern Healthcare) (Law 360-$)
  • Searching OPDP Letters Made Easier (Regulatory Rx)
  • Beyond Gender Bias-Lessons from the Female Libido Drug's Path To Approval (PCM)
  • Long, winding road to approval for new drugs (SF Chronicle)
  • 12-year-old NH boy with rare disease fights for FDA approval of drug (NECN)
  • Tech PR firm takes on Merck to save the life of an employee with kidney cancer (MedCity News)
  • FDA Gleans Compounding Funding Bump With Efficiencies, Research Cuts (IHP-$)
  • Canada Patent Protections In Spotlight As PhRMA Seeks Addition To "Priority Watch List" (Pink Sheet-$)
  • DSCSA: Transaction History (RxTrace)

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

  • Andarix Pharmaceuticals Receives Orphan Drug Designation from the FDA for Small Cell Lung Cancer (Press)
  • Eyeing rival mAb mob, Novartis touts PhIII secukinumab psoriasis data (Fierce)
  • Galderma Announces Positive Results of Phase 3 Trials of Investigational Ivermectin 1% Targeting Papulopustular Rosacea (Press)
  • Oral OTEZLA (apremilast) Demonstrated Clinically Meaningful and Sustained Improvements in Skin, Nail and Scalp of Adult Patients with Moderate to Severe Plaque Psoriasis (Press)
  • Pfizer Announces Detailed Results of OPT Compare Phase 3 Study of Tofacitinib 5 mg and 10 mg Twice Daily Compared to High-Dose ENBREL in Adults with Moderate-to-Severe Chronic Plaque Psoriasis (Press) (Pharma Letter-$)
  • Emmaus Sickle Cell Drug Hits Phase 3 Endpoints (Press)
  • Boehringer's nintedanib meets in Phase III IPF trials (BioCentury)

US: Pharmaceuticals and Biotechnology: General

  • Ohio bill: Make Zohydro illegal (Cincinnati Enquirer)
  • Colorado lawmakers to consider 'Buyers Club' bill (ABC)
  • Ethics, Regulation, and Comparative Effectiveness Research: Time for a Change (JAMA)
  • Biotech's Friday selloff: Are sector bears growling or just stretching? (Market Watch) (The Street)
  • WellPoint says new hepatitis c drug prices are too high (Reuters)
  • Obamacare plans bring hefty fees for certain drugs (AP)

US: Medical Devices

  • Medical Device Recalls Growing at Slower Pace Than Industry (Qmed) (FDA) (Fierce) (Mass Device) (Gray Sheet-$)
  • St. Jude Gets FDA Approvals for Three Types of Pacemakers (WSJ) (Press)
  • Bipartisan Group Of Senators Seeks FDA Advice On Medical Software Legislation (IHP-$)
  • Drug-Diagnostic Development Stymied by Payer Concerns (PharmExec)
  • Thoratec Recalls Heartmate II Pocket Controllers Over Backup Problem (FDA) (FDA) (FDA) (FDA)
  • Just Don't Call Them Hearing Aids: Amplifiers Take off (NYTimes)
  • Analyst Report Indicates that Health Care Organizations, Including Internet-connected Medical Devices, Are Vulnerable to Attack (Inside Medical Devices)
  • US: Dietary Supplements
  • NDI Notifications Are Not Swept Aside As New Drugs - FDA (Tan Sheet-$)
  • Don't be the Next Trudeau, Check Your Claims Now (NPI)
  • The Amendment that Meant More Than DSHEA (NPI)

US: Assorted And Government

  • FDA Searches Small Industry Candidate Pool To Fill Executive Vacancies (Pink Sheet-$)
  • FDA's Elevator Pitch To Potential Industry Recruits: No Dull Moments (Pink Sheet-$)
  • The FDA Funding Crisis (SAGE)
  • John Roth, Office of Criminal Investigations Director Leaves FDA, Phil Walsky becomes Acting OCI Director (FDA Alumni Association)
  • SCRIP Capitol Capsule (SCRIP-$)

Europe

  • NICE to rethink valuations of drugs for NHS (FT-$)
  • Proposed EU Law Would Require More Drug-Trial Transparency (WSJ-$) (Pharmafile)
  • MHRA literally shreds clinical trial info after 15 years (All Trials) (Sunday Times)
  • Italian Ruling on Roche and Novartis Resonates Across Europe (PharmExec)
  • Off-label Avastin in AMD: the European Commission gets involved (SCRIP-$)
  • UK's NICE unable to give the go ahead to new prostate cancer drug Xofigo (Pharma Letter-$) (Pharmafile) (Pharma Times) (Reuters)
  • EDQM launches new database to assist authorities in the fight against counterfeit/falsified medical products (EDQM)
  • G-BA finds no additional benefit for Eylea, Aubagio (BioCentury)
  • G-BA backs Bayer's Stivarga (BioCentury)
  • EU smiles on Lilly and Boehringer's FDA-rejected diabetes drug (Fierce)
  • Navidea inches closer to EU approval for its Lymphoseek Dx imaging agent (Fierce)
  • UK: Thousands of dementia sufferers should be offered drug trials (Telegraph)
  • Aerocrine: NICE (UK) Will Support the Use of Fractional Exhaled Nitric Oxide (FeNO) Measurement in Diagnosis and Management of Asthma (Press)

India

  • Merck HIV Drug Strategy Seen Shielding Patent: Corporate India (Bloomberg)

Japan & China

  • China Hopes To Implement Unique Device Identifier System By Year End (Gray Sheet-$)
  • Astellas Announces Marketing Approval in Japan for XTANDI(enzalutamide) Capsules, a Prostate Cancer Treatment (Press) (SCRIP-$)
  • AZ's Forxiga receives regulatory approval in Japan for the treatment of type 2 diabetes (Press) (Pharma Letter-$)
  • Otsuka Pharmaceutical's Samsca Approved in Japan as the World's First Drug Therapy for ADPKD, a Rare Kidney Disease (Press)

Other International

  • East African Community (EAC) validates technical documents for joint registration and evaluation of medicines (PharmAfrica)
  • Australia: Streamlining and improving therapeutic goods legislation (TGA)
  • Brazil's Cristalia gains ANVISA approval for production of biosimilar drugs (Pharma Letter-$)
  • Gilead offers Egypt new hepatitis C drug at 99 percent discount (Reuters) (BioCentury)

General Regulatory And Interesting Articles

  • New model proposed for clinical trials (MNT)
  • A Pirate-themed CT scanner (TIE)
  • Drugs from a Sloth's Back (Scientific American)
  • A Threat to Male Fertility: Phthalates (NYTimes)
  • Mobile app could offer inexpensive Dx in developing world (Fierce)
  • Computers see through faked expressions of pain better than people (Press)

Regulatory Reconnaissance #282 - 24 March 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.

Did we miss a story? Send us a tweet at @RAPSorg and we'll check it out for inclusion in our next edition of Regulatory Reconnaissance. Want this in your inbox each morning? Sign up for RF Today, our morning intelligence newsletter here.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @AlecGaffney or send him an email at news@raps.org.


Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe