Regulatory Focus™ > News Articles > Regulatory Recon: Legislators: $20 Million Price for Opioid Guidance (21 May 2014)

Regulatory Recon: Legislators: $20 Million Price for Opioid Guidance (21 May 2014)

Posted 21 May 2014 | By Alexander Gaffney, RAC 

Regulatory Recon: Legislators: $20 Million Price for Opioid Guidance (21 May 2014)

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.

In Focus: US

In Focus: International

US: Pharmaceuticals/Biotechnology

  • FDA Approves Takeda’s Entyvio for ulcerative colitis and Crohn's disease (Pharma Letter-$) (SCRIP-$) (Pharma Times) (BioCentury) (FDA) (Fierce) (Press)
  • House Legislators Demand Opioid Guidance in Return for Withheld Funding (Pink Sheet-$) (BioCentury) (IHP-$)
  • Mainers and FDC Act Preemption “In”, and PhRMA and Foreign Commerce Clause “Out” in Dispute Over Drug Importation Law (FDA Law Blog)
  • The Differences Between The DSCSA, FDA Rules and Guidance (RxTrace)
  • Masters Pharmaceutical fires back at FDA over seizure announcement (BizJournal)
  • Sunscreen Ingredient Legislation Could Ride Wave Of Momentum (Tan Sheet-$) (The Hill)
  • Health Subcommittee Discusses Accelerated Approvals and Clinical Trial Networks (E&C) (SCRIP-$) (BioCentury) (FDA Law Blog)
  • TPP Negotiators Said To Consider Middle Ground In Trial-Data Dispute (PharmAsia-$)
  • FDA’s New Module 1 (Cato)
  • Mini Sentinel to Assess the Association of Thromboembolic Events After Immunoglobulin Administration (Mini Sentinel)
  • Side effect analysis suggests Gilead's hep C wonder Sovaldi is safer than rivals, too (Fierce)
  • GSK, Genmab likely won’t seek FDA approval for lymphoma drug after failed trial (MedCity News)
  • A New Kind Of Free Speech: Drug Reps’ Pitches To Doctors (New Yorker)

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

  • Gilead's GS-5806 meets in RSV challenge study (BioCentury) (Press)
  • Provectus Disappears 'Breakthrough' Drug Claim on Web Site (The Street)
  • PDUFA Date for Baxter's Hyqvia BLA Pushed Back (Press)
  • AbbVie's Humira wins orphan drug status for uveitis (Pharma Times)
  • Karyopharm gets second orphan drug designation in two days (BioFlash)

US: Pharmaceuticals and Biotechnology: General

US: Medical Devices

  • The Life Cycle of Medical Product Rules Issued by the US Food and Drug Administration (PubMed)
  • 'Brain-hacking' devices may not be safe but they're selling (Mass Device)
  • Can an app mimic the effect of medication? New crowdfunding campaign seeks answers (MedCity News)
  • Proa Medical Receives 510(k) Clearance from FDA for Brella-Spec Vaginal Speculum for Gynecological and Obstetrical Procedures (Press)
  • ERBA Diagnostics, Inc. Receives 510(K) Clearance for the XL200 Clinical Chemistry Analyzer (Press)
  • Class 1 Device Recall Infant Nasal CPAP (FDA)
  • Class I Recall for CareFusion's Alaris Pump Module (FDA)

US: Dietary Supplements

  • NPA's Fabricant: 'There have to be prosecutions' (NI-USA)

US: Assorted And Government

  • House, Senate release FDA FY15 funding bills (BioCentury)
  • Panel to cut red tape gains Dem support (The Hill) (The Bill)
  • Burwell Defends OMB Decision To Sequester FDA User Fees (IHP-$)

Europe

  • EMA criticized for flip-flopping on clinical trial data transparency (Fierce) (BMJ) (Outsourcing Pharma) (Pharma Times) (PharmExec)
  • Comparing the Effectiveness of Prescription Drugs: The German Experience (CAP)
  • NICE rejects Revlimid for myelodysplastic syndromes (PharmaPhorum) (Pharma Times)
  • Medtronic wins a CE mark for its NC Euphora balloon catheter (Fierce) (Mass Device) (Press)
  • Phase III SIGNIFY data prompt EU Procoralan investigation (SCRIP-$)
  • EMA meets to review evidence that body weight affects efficacy of emergency contraceptives (PJO)

India

  • DCGI to spend Rs 3,000 crore to set up labs, double drug regulators (India Times)
  • Pharmexcil urges commerce ministry to seek WTO's intervention on MHRA ban on herbal products (PharmaBiz)

Japan & China

  • China FDA reports increase in adverse drug reaction reports (Pharma Letter-$)
  • ‘Idiotic’ Name for Dementia Sparks China Doctors’ Protest (Bloomberg)

Other International

  • TGA's guidance on clinical trial data and commercially confidential information (Lexology)
  • Potential medical pot fraud raised fears at Health Canada (CBC)

General Regulatory And Interesting Articles

  • Reckitt Benckiser to co-develop nasal spray to treat opioid overdose (In-Pharma)

Regulatory Reconnaissance #323 – 21 May 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.

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


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