Regulatory Focus™ > News Articles > Regulatory Recon: CDER on Track for Another Strong Year (14 July 2014)

Regulatory Recon: CDER on Track for Another Strong Year (14 July 2014)

Posted 14 July 2014 | By Alexander Gaffney, RAC 

Regulatory Recon: CDER on Track for Another Strong Year (14 July 2014)

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

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In Focus: US

In Focus: International

  • PhRMA Blasts NICE Over Cancer Drug Coverage Decisions (PhRMA)
  • Guide on methodological standards in pharmacoepidemiology revised to include pharmacogenetic studies (EMA)
  • EMA's CVMP Approves New Products (EMA)
  • EMA Adopts ICH Q4B Annex 6 (EMA)
  • India Cuts Prices of 108 Drugs (India Times)
  • Dosing by the spoonful can lead to medicine errors, researchers warn (WaPo) (NBC)

US: Pharmaceuticals and Biotechnology

  • CDER Builds Strong Foundation Of NMEs For 2014 As Approval Total Hits 19 (Pharmafile)
  • Drug Sample Reporting: FDA Doesn’t Want Signatures, But Firms Need Them On File (Pink Sheet-$) (Policy and Medicine) (FDA)
  • Woodcock Encourages Patient Groups To Take Lead To Speed Regulatory Process, Development (Pink Sheet-$) (FDA) (IHP-$)
  • Woodcock, Eichler: Accelerated Access to Innovative Medicines for Patients in Need (PubMed)
  • FDA's Social Media Webinar Q&A (FDA)
  • FDA AdComm to Discuss BLA for Secukinumab (FDA)
  • Joint Meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee (FDA)
  • The Dangers of Mixing Libertarianism and Access to Experimental Medicines (DrugWonks)
  • Stakeholders want streamlined clinical trials (BioCentury) (SCRIP-$) (E&C)
  • FDA to Hold Public Meeting on Antimicrobial Resistance Monitoring in the Food Supply (FDA) (FR)
  • Sun issues third recall since announcing deal to buy Ranbaxy (Fierce)
  • Safe And Affordable Drugs From Canada Act Of 2014 (Bill)
  • Iowa High Court Spares Wyeth From Generics Injury Claims (Law 360-$)
  • The Limits of Evidence in Drug Approval and Availability: A Case Study of Cilostazol and Naftidrofuryl for the Treatment of Intermittent Claudication (PubMed)
  • Designing Pre-Market Observational Comparative Studies Using Existing Data as Controls: Challenges and Opportunities (PubMed)
  • Medac Pharma, Inc. Secures FDA Approval of Rasuvo (methotrexate) injection for Rheumatoid Arthritis, Poly-Articular-Course Juvenile Idiopathic Arthritis and Psoriasis (Press)
  • FDA Office of Drug Evaluation III Approves Salix’s Request that the FDA Approve the RELISTOR Subcutaneous Injection sNDA for the Treatment of Opioid-induced Constipation in Patients with Chronic Non-cancer Pain (Press)
  • Hospira Lactated Ringer's And 5% Dextrose Injection, 1000 ML, Flexible Containers: Recall (One Lot) - Mold Contamination (FDA) (FDA)
  • Sterile Drug Products by Unique Pharmaceuticals Ltd.: Alerting Health Care Professionals - Lack of Sterility Assurance (FDA)

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

  • Teva Announces FDA Acceptance of NDA Filing for Investigational Short-Acting Beta-Agonist (SABA) Inhaler (Albuterol MDPI) (Press)
  • Otsuka and Lundbeck Submit New Drug Application in the US for Brexpiprazole for the Treatment of Schizophrenia and as Adjunctive Therapy for the Treatment of Major Depressive Disorder (Press)
  • Roche combination drug for melanoma impresses (Pharmafile) (Reuters)
  • Genentech’s Investigational Medicine Cobimetinib, Used in Combination with Zelboraf (Vemurafenib), Helped People with Advanced Melanoma Live Significantly Longer Without Their Disease Worsening (Press)
  • FDA Grants Special Protocol Assessment (SPA) Agreement for Starpharma Phase 3 Recurrent BV Trial (Press)
  • New Data Shows Combination Therapy is More Effective than Monotherapy in Removing Beta-Amyloid Plaques from the Brains of Mice (Press)
  • Exelixis Announces Positive Top-Line Results for Phase 3 Pivotal Trial of Cobimetinib in Combination With Vemurafenib in Patients With BRAF V600 Mutation-Positive Advanced Melanoma (Press)

US: Pharmaceuticals and Biotechnology: General

US: Medical Devices

  • Fed panel: laparoscopic fibroid removal may spread unseen cancer (Modern Healthcare-$) (Fierce) (Mass Device) (Democrat & Chronicle) (Fierce) (Forbes) (WSJ-$)
  • Doc Quits FDA Panel Reviewing J&J Device Over Conflict of Interest (Pharmalot) (WSJ-$)
  • Robot surgery becomes a poster child for curbing new health tech (Mass Device)
  • ONC's 6 new working groups (Gov Health IT) (Fierce)
  • More good news for Abbott's MitraClip in JACC study (Mass Device)
  • Warning letter prompts lawsuit against Staar Surgical (Mass Device)
  • Titan Spine Receives FDA Clearance to Launch Endoskeleton TL Device for Lateral Spinal Fusion (Press)
  • Paragonix Technologies Inc., Announces Filing of a 510(k) Pre-market Notification with the US Food and Drug Administration for the Paragonix Sherpa Perfusion™ Cardiac Transport System (Press)

US: Dietary Supplements

  • ‘Not all omega-3 supplements are created equal, at least in terms of CVD risk reduction’, says new study (NI-USA)
  • Vitamin Shoppe's move to put all labels into public database increases transparency, CRN chief says (NI-USA)
  • US: Assorted And Government
  • After Lapses, C.D.C. Admits a Lax Culture at Labs (NYTimes) (Reuters) (SCRIP-$) (AP) (NBC) (WaPo) (Reuters) (NYTimes) (MedPage Today) (NPR)

Europe

  • PhRMA Blasts NICE Over Cancer Drug Coverage Decisions (PhRMA)
  • Guide on methodological standards in pharmacoepidemiology revised to include pharmacogenetic studies (EMA)
  • CVMP Approves New Products (EMA)
  • EMA Adopts ICH Q4B Annex 6 (EMA)
  • ARIAD Announces Continuation of Iclusig Review under the Article 20 Procedure in Europe (Press)
  • Sigma-Tau Submits EMA Application for ALL Drug (Press)
  • Boston Scientific Receives CE Mark For Ranger Drug-Coated Balloon (Press)
  • British Government Picks Illumina to Sequence 100,000 Genomes (MIT Tech Review)
  • Access to Medicines Account for Differences in Survival Rates in EU (Press)

India

  • India Cuts Prices of 108 Drugs (India Times)
  • Drug control officers demand technically qualified persons to head DCA in Telangana, AP (PharmaBiz)

Other International

  • Malaysian medical device regulators change requirements for DoCs, AI requests (Mass Device)

Clinical Trials

  • Better use of electronic health records makes clinical trials less expensive (MNT)

General Regulatory And Interesting Articles

  • Dosing by the spoonful can lead to medicine errors, researchers warn (WaPo) (NBC)
  • Study: Actos cuts Alzheimers Risk (Reuters)
  • Mind the mo: Moustaches may raise burn risk with home oxygen therapy (MedCityNews)

Regulatory Reconnaissance #356 – 14 July 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.

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


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