Regulatory Focus™ > News Articles > Regulatory Recon: Was PDUFA Bad for the Public? Maybe Not… (6 August 2014)

Regulatory Recon: Was PDUFA Bad for the Public? Maybe Not… (6 August 2014)

Posted 06 August 2014 | By Alexander Gaffney, RAC 

Regulatory Recon: Was PDUFA Bad for the Public? Maybe Not… (6 August 2014)

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

This fall, regulatory professionals from across the globe will come together to learn, connect and share at the Regulatory Affairs Professionals Society’s 2014 RAPS: The Regulatory Convergence, 27 September-1 October, Austin, TX.  Register by 29 August 2014 to receive the lowest rate.

In Focus: US

  • Did PDUFA Sacrifice Safety for Speed? Maybe Not… (MedPage Today)
  • How Can Patients be Included in the Drug Approval Process? (FasterCures)
  • FDA Issues Draft Guidance for Industry on Cell-Based Products for Animal Use (FDA) (FDA) (FR)
  • Give FDA Authority Over All Medical Device Ads? (MDDI)
  • How Useful is Social Media in Medical Device Adverse Event Surveillance? (PubMed)
  • 5 Takeaways From FDA Medical Device Data System Guidance (Law 360-$)
  • Advice for the Next Head of FDA’s Division of Dietary Supplements (Nutritional Outlook)

In Focus: International

  • Roche's Avastin gets new EU nod in ovarian cancer (PMLIve) (Pharmafile) (Reuters) (Press)
  • Should the EMA be allowed to censor independent analysis of side effect data? (AllTrials)
  • Bayer moves to block BDR's generic Nexavar in India (SCRIP-$)
  • Controversial India State FDA Commissioner Ousted (PharmAsia-$)
  • PIC/S adopts EU GDP Guidelines (ECA)

US: Pharmaceuticals and Biotechnology

  • HypeWatch: Did PDUFA Sacrifice Safety for Speed? Maybe Not… (MedPage Today)
  • How Can Patients be Included in the Drug Approval Process? (FasterCures)
  • FDA Issues Draft Guidance for Industry on Cell-Based Products for Animal Use (FDA) (FDA) (FR)
  • The Neglect of Tropical Diseases (Vox)
  • 2 New MaPPs (to Somewhere) that Provide Direction on ANDA Supplements and Amendments (Lachman)
  • Advancing the Use of Biomarkers and Pharmacogenomics; Notice of Public Meeting (FDA)
  • Can Embedded Tweets Help Pharmaceutical Companies Use Twitter? (RegulatoryRx)
  • Cubist Pharmaceuticals Issues Voluntary U.S. Recall of Certain Lots of CUBICIN (daptomycin for injection) 500 mg in 10 mL single use vials Due to Presence of Particulate Matter (Press)
  • Fresenius: US supply from troubled Indian plant to restart in Q3 (In-Pharma)

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

US: Pharmaceuticals and Biotechnology: General

  • Experimental Ebola treatment given to Americans, but when will regulatory pathway extend to sick Africans? (MedCity News)
  • Mapp to increase ZMapp production for Ebola (BioCentury)
  • Can we give that experimental Ebola drug to West African victims? (WaPo)
  • Teva eyes 'hard switch' to hit Copaxone goals if the soft sell isn't enough (Fierce)
  • Suspicious Prescriptions for HIV Drugs Abound in Medicare (ProPublica)
  • Do PBM’s recent formulary restrictions point to an increased role for cost-effectiveness analysis in the U.S.? (CEA)

US: Medical Devices

  • FDA Warns About Adverse Events Associated With Intranasal Splint Being Used as a Dermal Filler (FDA) (FDA)
  • Give FDA Authority Over All Medical Device Ads? (MDDI)
  • Participatory surveillance of diabetes device safety: a social media-based complement to traditional FDA reporting (PubMed)
  • 5 Takeaways From FDA Medical Device Data System Guidance (Law 360-$)
  • FDA, ONC Endorse Including UDIs In Claims Despite Providers' Concerns (IHP-$)
  • GE’s New SIGNA PET/MR with Time-of-Flight Tech Under Review by FDA (MedGadget)
  • ElMindA announces FDA clearance of brain analysis and mapping technology (MNT) (Medical Design)
  • Proteus Digital Health study finds system detects pill ingestion 99.1 percent of the time (MobiHealthNews)
  • Scientists Dream of 'Holy Grail' Device to Detect Ebola (NBC)

US: Dietary Supplements

  • Advice for the Next Head of FDA’s Division of Dietary Supplements (Nutritional Outlook)
  • CRN, NPA submit comments on FDA's proposed changes to food, supplement labels (NI-USA)
  • Aide: Virginia First lady tried to pitch supplement to Mitt Romney (WaPo)

US: Assorted And Government

  • As Congress Eyes Medical Innovation, FDA, NIH Stakeholders Push Consortia (IHP-$)
  • The Ontology of Adverse Events (PubMed)
  • Feds Charge Biogenesis Exec, Others In MLB Doping Scandal (Law 360-$)
  • FDA Spending Big Bucks on Media Monitoring (FDA)
  • Poll: Pharmas, health insurers least trusted businesses (SCRIP-$)

Europe

  • Roche's Avastin gets new EU nod in ovarian cancer (PMLIve) (Pharmafile) (Reuters) (Press)
  • Should the EMA be allowed to censor independent analysis of side effect data? (AllTrials)
  • Pfizer’s arthritis drug Enbrel widens its European licence (PMLIve) (Pharma Times)
  • European Commission publishes approval of Octapharma’s human cell line recombinant FVIII (Nuwiq) across all age groups in haemophilia A (Press)
  • UK asks: which prescription drugs are least likely to be falsified? (SCRIP-$)

India

  • Bayer moves to block BDR's generic Nexavar in India (SCRIP-$)
  • Controversial India State FDA Commissioner Ousted (PharmAsia-$)
  • India Leans On IT To Monitor Trials, Add Transparency (PharmAsia-$)
  • DCGI bars Pregna Intl from manufacturing medical device 'Tcu 380Ag' in6 violation of D&C Act (PharmaBiz)

China

  • New Chinese medical device, IVD regulations take effect in October 2014 (Emergo)

Japan

  • Lombard Medical scores Japanese approval for endovascular stent graft system (Fierce)

Canada

  • Health Canada Approves ABRAXANE Plus Gemcitabine for First-Line Treatment of Patients with Metastatic Pancreatic Cancer (Press)

Australia

  • NanoString Technologies Receives Market Approval From the Australian Therapeutic Goods Administration for Its Prosigna Breast Cancer Prognostic Gene Signature Assay (Press)
  • Other International
  • PIC/S adopts EU GDP Guidelines (ECA)

Clinical Trials

  • eSource Data in Clinical Investigations: FDA Clarifies Guidance on Regulatory Considerations (BioClinica)

General Regulatory And Interesting Articles

  • Talkitt App Clears Garbled Speech of People with Disabilities (MedGadget)
  • Aspirin a day could dramatically cut cancer risk, says biggest study yet (Guardian) (Reuters)
  • Drug-Resistant Malaria Spreads Across Southeast Asia (NPR)
  • Nearly 10 percent of patients with cancer still smoke (Press)

Regulatory Reconnaissance #373 – 6 August 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

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