Regulatory Focus™ > News Articles > Regulatory Reconnaissance: FDA Smacks Down Aspirin Claims (5 May 2014)

Regulatory Reconnaissance: FDA Smacks Down Aspirin Claims (5 May 2014)

Posted 05 May 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.

In Focus: US

  • FDA Denies Bayer Petition on Use of Aspirin to Prevent Heart Attack, Stroke (FDA) (Petition Denial)
  • GDUFA Deadlines Could Cause ANDA Applicants To Lose Exclusivity (Pink Sheet-$)
  • Panel Recommends Against OTC Singulair Due To Off-Label Use Risk (Tan Sheet-$) (SCRIP-$) (MedPage Today)
  • PhRMA, BIO say FDA too broad in social media regulation (BioCentury)
  • UDI Deadline For Class III Medical Devices Quickly Approaching (RxTrace)
  • FDA Releases New MDUFA Performance Report (FDA)
  • FTC Targets Disclosures, "Up To" And "Doctor Recommended" Claims (Tan Sheet-$)

In Focus: International

  • EMA Issues First Report on Pharmacovigilance Legislation (EMA) (Report)
  • EMA publishes 2013 annual report (EMA)
  • EMA to accept pCR as breast cancer endpoint (BioCentury)
  • Indian Government mulls cancer drug patent waiver for Dasatinib (India Times)

US: Pharmaceuticals/Biotechnology

  • FDA Denies Bayer Petition on Use of Aspirin to Prevent Heart Attack, Stroke (FDA) (Petition Denial)
  • GDUFA Deadlines Could Cause ANDA Applicants To Lose Exclusivity (Pink Sheet-$)
  • Panel Recommends Against OTC Singulair Due To Off-Label Use Risk (Tan Sheet-$) (SCRIP-$) (MedPage Today)
  • PhRMA, BIO say FDA too broad in social media regulation (BioCentury)
  • BIO Weighs in on New NCE Policy (FDA)
  • US FDA stings scorpion anti-venom biomanufacturer with Warning Letter (BioPharma Reporter)
  • FDA Approves Conversion of Soliris (eculizumab) Accelerated Approval in aHUS to Regular Approval for the Treatment of Patients with aHUS (Press)
  • Hospira says biosimilar approval likely in US by 2016 (BioPharma Reporter)
  • Generics Don't Need To Prove What Isn't In Brand's Label - FDA Petition Denial (Pink Sheet-$)
  • US FDA asks Indian pharma leaders to make quality, their top priority (India Times)
  • Boning Up: FDA Revisits Pre-MMA 180-Day Exclusivity and Addresses a New Scenario (FDA Law Blog)
  • Throckmorton Presentation on the Impact of Abuse-Deterrent Formulations of Opioids (FDA)
  • Q&A: GSK Regulatory Head Huckle Talks About Life Under FDASIA (Pink Sheet-$)
  • USP Faces New Challenges (PharmTech Talk)
  • FDA Approves Teva's SYNRIBO (Omacetaxine Mepesuccinate) for Injection for Home Administration (Press)
  • Hospira: New Vizag plant online this year despite US FDA 483 (BioPharma Reporter)
  • California senate advances bill to curb antibiotics in farm animals (Reuters)

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

  • Novartis says Signifor LAR drug helps control acromegaly disease (Reuters)
  • Enrollment in Merck, Endocyte vintafolide study stopped for futility (SCRIP-$) (Fierce) (Pharma Times)
  • FDA issues orphan drug designation to OncoMed's pancreatic cancer drug (PBR)

US: Pharmaceuticals and Biotechnology: General

  • Maine pharmacy board wants probe of Canadian drug company (AP)
  • State AGs Urge 3rd Circ. To Reverse Pay-For-Delay Ruling (Law 360-$)
  • DEA to boost marijuana supply for research (The Hill)
  • Soldier Blames Murder on Chantix (The Telegraph)
  • Why make new antibiotics when no one is paying for them? (QZ)

US: Medical Devices

  • UDI Deadline For Class III Medical Devices Quickly Approaching (RxTrace)
  • FDA Releases New MDUFA Performance Report (FDA)
  • CDRH Launches Compliance and Enforcement Webpage (FDA)
  • Laxatives Fail You? Try a Vibrating Pill (NBC)
  • Recall for Baxter's Infusion Pumps (FDA)

US: Dietary Supplements

  • FTC Targets Disclosures, "Up To" And "Doctor Recommended" Claims (Tan Sheet-$)
  • USP Door Open For Input On Supplement Ingredient Reference Standards (Tan Sheet-$)

US: Assorted And Government

  • BioCenturyTV Discussion With Rep. Anna Eschoo About FDA (BioCentury)
  • SCRIP US Capitol Capsule (SCRIP-$)

Europe

  • EMA Issues First Report on Pharmacovigilance Legislation (EMA) (Report)
  • EMA publishes 2013 annual report (EMA)
  • EMA to accept pCR as breast cancer endpoint (BioCentury)
  • 2013 annual report on EudraVigilance: over 1 million adverse reaction reports received and processed (EMA)
  • 10 questions on UK's early access scheme answered (SCRIP-$)
  • IQWiG backs Sovaldi for HCV genotype 2 only (BioCentury) (Pharma Letter-$)

India

  • Indian Government mulls cancer drug patent waiver for Dasatinib (India Times)
  • US wants more transparency on India's inter-ministerial panel on compulsory license issue (PharmaBiz)
  • Two criminal cases await Ranbaxy pharmaceuticals in Kerala (India Times)

General Regulatory And Interesting Articles

  • Regulatory Chemistry, Manufacturing and Controls Requirements for using Comparator Drug Products in Clinical Trials (Ask CATO)
  • Are ADHD medicines safe for kids? Researchers find scant long-term evidence alarming (MedCityNews)
  • FITGuard Mouth Guard to Detect Head Impacts That Lead to Concussions (MedGadget)

Regulatory Reconnaissance #311 - 5 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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