Regulatory Focus™ > News Articles > Regulatory Recon: Lawsuit Wants FDA to Require Gluten Labeling on Medicines (18 March 2015)

Regulatory Recon: Lawsuit Wants FDA to Require Gluten Labeling on Medicines (18 March 2015)

Posted 18 March 2015 | By Alexander Gaffney, RAC

Regulatory Recon: Lawsuit Wants FDA to Require Gluten Labeling on Medicines (18 March 2015)

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

In Focus: US

  • FDA is Sued for Failing to Regulate the Use of Glutens in Medicines (Pharmalot) (Lawsuit)
  • Sklamberg: FDA plans to shift to an incentive based from a penalty based audits (India Times) (Fierce)
  • FDA team to sign deal with Indian regulators on information sharing (BusinessLine) (PharmAsia-$)
  • Amarin Says FDA Changed Rules To Deny Market Exclusivity (Law 360-$)
  • Holy Grail: Pain Pills Without the High (WSJ-$)
  • Public Citizen's Wolfe: FDA should have withdrawn Crestor (OnMedica) (BMJ)
  • Vaccine Court’s Tough Standards May Face Supreme Court Test (Bloomberg)
  • Boston Scientific wins CE Mark, FDA nod for smaller 'leadless' ICD (Mass Device) (Press)
  • UDI Setback—‘Ships That Pass in the Night’ (MDDI)
  • Consumers Breeze Past Label Disclaimers on Supplements (MedPage Today)

In Focus: International

  • Guido Rasi looks at how the EU regulatory landscape might change over the next decade (SCRIP-$)
  • The EMA at 20: CAT chair on where all the advanced therapies are (SCRIP-$)
  • Celebrating 20 years: EMA launches anniversary book (EMA) (Book)
  • Why Chinese Tourists Are Wild Over Japanese Drugs (It’s Not Just the Quality) (WSJ-$)
  • Canada Needs More Transparency in Pharmaceutical Regulation (Huffington Post)
  • Battle in Australia over access to cancer drugs (PharmaTimes)

Learn About--and Help Shape--FDA's Draft Combo Products GMP Guidance

  • When it comes to combination products, more regulations can mean more difficulties for regulatory professionals. That's why we've teamed up with the Combination Products Coalition (CPC) to offer a full day interactive program focused on FDA's newest draft guidance on Good Manufacturing Practices (GMPs) for combination products. Learn from FDA experts and industry veterans in this unique experience that will help agency regulators to shape and clarify the final guidance document. [Register here]

US: Pharmaceuticals and Biotechnology

  • FDA is Sued for Failing to Regulate the Use of Glutens in Medicines (Pharmalot) (Lawsuit)
  • Sklamberg: FDA plans to shift to an incentive based from a penalty based audits (India Times) (Fierce)
  • FDA team to sign deal with Indian regulators on information sharing (BusinessLine) (PharmAsia-$)
  • Amarin Says FDA Changed Rules To Deny Market Exclusivity (Law 360-$)
  • Holy Grail: Pain Pills Without the High (WSJ-$)
  • Public Citizen's Wolfe: FDA should have withdrawn Crestor (OnMedica) (BMJ)
  • Vertex Receives U.S. Food and Drug Administration Approval of KALYDECO (ivacaftor) for Children with Cystic Fibrosis Ages 2 to 5 who have Specific Mutations in the CFTR Gene (Press)
  • Discussion on Clinical Considerations of Risk in the Postmarket Environment (FDA)
  • Arkansas lawmakers approve abortion pill restrictions (Arkansas Online)
  • Indiana State Senate approves “Right to Try” bill (WishTV)
  • Idaho Bill Would Expand Access to Investigational Drugs (Scout)
  • Asthma Warnings Not Working Well, FDA Fears As GSK Seeks Expanded LABA Approval (Pink Sheet-$) (Pink Sheet-$) (Tarius)
  • BIO Urges Governor Herbert to Sign Bill That Ensures Patient Access to Interchangeable Biologic Medicines (Press)

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

  • AstraZeneca two-in-one drug succeeds in lung disease test (Reuters) (Press) (Pharmafile)
  • Nektar drug fails late-stage study in breast cancer patients (Reuters) (Fierce)
  • DEA approves study using MDMA for anxiety in seriously ill patients (Al Jazeera)

US: Pharmaceuticals and Biotechnology: General

  • Vaccine Court’s Tough Standards May Face Supreme Court Test (Bloomberg)
  • Top 15 pharma companies by 2014 revenue (Fierce)
  • Report: U.S. Pharmaceutical Market to Increase by 40% by 2020 (Press) (Press)
  • Paying Physicians to Prescribe Generic Drugs and Follow-On Biologics in the United States (PLoS)
  • Mississippi Wants Execution-Drug Supplier's Name Kept Secret (AP)
  • Xcelience Receives DEA Approval to Develop and Manufacture DEA Schedule I Drug Products (Press)

US: Medical Devices

  • Boston Scientific wins CE Mark, FDA nod for smaller 'leadless' ICD (Mass Device) (Press)
  • UDI Setback—‘Ships That Pass in the Night’ (MDDI)
  • Sen. Warren responds to CMS' opposition to UDI, says she expects agency to resolve issues (Fierce)
  • The impact of companion diagnostic device measurement performance on clinical validation of personalized medicine (PubMed)
  • Device manufacturer sued again in 'superbug' outbreak at L.A. hospital (Reuters)
  • FDA Clears Quidel's Trichomonas Assay (GenomeWeb)
  • Class 1 Recall for Medtronic's FlexCath Select Steerable Sheath (FDA)
  • FDA clears iPad medical app for measuring surgical blood loss in canisters (MobiHealthNews)
  • It had to happen: Apple Watch gets a drug-adherence app (Fierce)
  • Regulatory Framework for Clinical Decision Support Software: Present Uncertainty and Prospective Proposition (PubMed)
  • Etiometry Receives FDA 510(k) Clearance for its T3 Monitor (Press)

US: Dietary Supplements

  • Durbin, Feinstein, Blumenthal To FDA: Use Existing Authority To Protect Consumers From Contaminated Dietary Supplement (Senate)
  • Consumers Breeze Past Label Disclaimers on Supplements (MedPage Today)

US: Assorted And Government

  • House GOP calls for regulatory reform in budget proposal (The Hill)
  • FDA to roll back 'lost pleasure' approach on health rules (Reuters)

Upcoming Meetings and Events

Ebola Outbreak

  • Emergent BioSolutions to team its Ebola vaccine with GSK's in Phase I (SCRIP-$)
  • Equatorial Guinea Holds Malaria Vaccine Trial (PharmPro)

Europe

  • Live Stream of EMA's 20th Anniversary Conference (EMA)
  • Guido Rasi looks at how the EU regulatory landscape might change over the next decade (SCRIP-$)
  • The EMA at 20: CAT chair on where all the advanced therapies are (SCRIP-$)
  • Celebrating 20 years: EMA launches anniversary book (EMA) (Book)
  • Requirements on Submissions for PSURs updated (MRP/DCP, National) (Exalon)
  • Genzyme in breach of ABPI Code over Fabry drug (PharmaPhorum)

India

  • With grey areas aplenty, India's marketing code in autopilot? (SCRIP-$)
  • Few takers for indigeniously developed cheap H1N1 test kits (India Times)

China

  • Why Chinese Tourists Are Wild Over Japanese Drugs (It’s Not Just the Quality) (WSJ-$)

Canada

  • Canada Needs More Transparency in Pharmaceutical Regulation (Huffington Post)

Australia

  • Battle in Australia over access to cancer drugs (PharmaTimes)
  • Consumer watchdog to appeal federal court decision on Pfizer (Guardian)

Other International

  • Doing No Harm? Adverse Events in a Nation-Wide Cohort of Patients with Multidrug-Resistant Tuberculosis in Nigeria (PubMed)

General Regulatory And Interesting Articles

  • One Size Doesn't Fit All: Prosthetic Devices too Often Designed Just for Men (Vice)
  • How Evolved Is Your Quality Management System? (MasterControl)
  • New Super Fast 3D Printing Process Turns A Pile Of Goo Into An Eiffel Tower (Digg) (Vox)
  • Grab a bracket, pick your favorite drug names and get ready to dance: FierceMadness is here! (Fierce)
  • Animal rights protests have had little impact on preclinical services sector say CROs (BioPharma-Reporter)

Regulatory Reconnaissance #516 – 18 March 2015

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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