Regulatory Focus™ > News Articles > Regulatory Reconnaissance: Why is Apple Meeting with CDRH? (3 February 2014)

Regulatory Reconnaissance: Why is Apple Meeting with CDRH? (3 February 2014)

Posted 03 February 2014 | By Alexander Gaffney, RAC 

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In Focus: US

In Focus: International

  • EMA announces next steps for the maintenance of information on authorised medicines by marketing-authorisation holders (EMA)
  • Sweeping changes to Scottish drug approval system (OnMedica)
  • EU Tamper-Evident Packaging Requirement To Cost Generics Firms $700M (Pink Sheet-$)
  • Growing Pains: The European Medicines Agency at 20 (PharmExec)
  • France's ANSM Releases 2014 Regulatory Agenda (ANSM)
  • Beijing FDA Introduces New Regs On Advertisements For Drugs, Devices, And Dietary Supplements (PharmAsia-$)

US: Pharmaceuticals/Biotechnology

  • Janet Woodcock's Quality Agenda At CDER (Life Science Leader)
  • Doctor Challenges Testing of AztraZeneca's Brilinta (WSJ-$)
  • FDA approves Vanda's sleep disorder drug for blind people (PMLive) (MedPage Today) (Pharma Letter-$) (FDA) (Press) (Reuters) (BioCentury) (Bloomberg) (SCRIP-$)
  • FDA's Clinical Trial Inclusion Policy Sold As Mild And Gentle (Pink Sheet-$) (SCRIP-$)
  • With Waxman, Congressional Health Care Giant, Set To Retire, Eyes On Pallone For Top E&C Democrat Slot (IHP-$)
  • How Can FDA Refresh its Leadership in CDER? (BioCenturyTV)
  • Track-And-Trace: With Deadline A Year Away, Some Lessons From Early Adopters (Pink Sheet-$)
  • Once More Unto The Breach: 2014 NME Candidates Crowd In Familiar Fields (Pink Sheet-$)
  • R&D Productivity Still Lags: Study Shows Success Rates May Have Been Overestimated (Pink Sheet-$)
  • Mensing - It's Not Just About Generics Anymore (D&D Law)
  • Greater Clarity Needed Regarding What Scientific Information Biopharmaceutical Companies Can Communicate to Healthcare Providers (PhRMA)
  • AstraZeneca Wins One Battle, But Loses Another (And Perhaps the War) on SYMBICORT Patent Term Extension (FDA Law Blog)
  • Capitalizing on Fecal Transplants (Harvard BOH)
  • FDA Seeking Public Input on Animal Drug User Fee Act Information Collection (FDA)
  • B. Braun Receives FDA Approval For Next Generation 1L Intravenous Containers (Press)
  • Lilly Responds to Sanofi Suit, Stands by NDA (Press)

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

  • AbbVie aims to bring hepatitis drugs to US market this year (SCRIP-$) (Fierce) (AP) (Reuters)
  • GlaxoSmithKline Gains FDA Breakthrough Therapy Designation for Promacta/Revolade for Severe Aplastic Anemia (Press)
  • Phase III Trial Shows Astellas' Lenvatinib Meets Primary Endpoint Of Progression Free Survival Benefit In Treatment Of Radioiodine-Refractory Differentiated Thyroid Cancer (Press)
  • Pfizer Announces Positive Top-Line Results From PALOMA-1 Evaluating Palbociclib Plus Letrozole in Women with Advanced Breast Cancer (Press) (Reuters)
  • GSK to launch late-stage clinical trials on 10 new drugs (Telegraph)
  • Last remaining trial for Aveo's lead cancer drug cancelled (BioFlash)

US: Pharmaceuticals and Biotechnology: General

  • Hopes of family, firm collide on unproven drug (Boston Globe)
  • California students to get experimental meningitis vaccine (NBC) (Reuters)
  • Wisconsin Drug Disposal Bill Moves Forward (Scout)

US: Medical Devices

  • Apple Executives Met With F.D.A. to Discuss Mobile Medical Applications (NYTimes) (Verge)
  • J&J Works Toward Device Data-Sharing Agreement Following Pharma Plan (Gray Sheet-$)
  • Device Co. Pleads Guilty To Hiding Toxicity Data From FDA (Law 360-$)
  • Given Imaging gets FDA clearance for colon camera pill (Reuters)
  • FDA Releases New GUDID Overview (FDA)
  • Update on Litigation in Looney v. Moore (SUPPORT Trial Class Action) (Harvard BOH)

US: Dietary Supplements

  • Omega-3 Petition Outcome Will Reveal FDA Biomarker Stance (Tan Sheet-$)
  • YoungYou International Issues Voluntary Recall of Mega Slim Herbal Appetite Management Pills Due to Presence of DMAA (FDA)

US: Assorted And Government

  • US Capitol Capsule: White House, NIH seek to root out irreproducible science (SCRIP-$)
  • Unfinished GU Cancer Trials Called a 'Waste' (MedPage Today)

Upcoming Meetings And Events

  • 19 February 2014: FDA OAGS Small Business Outreach Vendor Fair (FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

  • EMA announces next steps for the maintenance of information on authorised medicines by marketing-authorisation holders (EMA)
  • Sweeping changes to Scottish drug approval system (OnMedica)
  • EU Tamper-Evident Packaging Requirement To Cost Generics Firms $700M (Pink Sheet-$)
  • Growing Pains: The European Medicines Agency at 20 (PharmExec)
  • France's ANSM Releases 2014 Regulatory Agenda (ANSM)
  • Chance of a positive benefit assessment in Germany: less than 30% (SCRIP-$)
  • Committee for orphan medicines - overview of 2013 and looking ahead (EMA)
  • ANSM issues a new version of their electronic submission form (Exalon)
  • Minutes from EUnetHTA-EMA meeting 10 December 2013 available (EMA)
  • EMA Adopts ICH Q4B Annex (EMA)
  • TECFIDERA (Dimethyl Fumarate) Approved in the European Union as a First-Line Oral Treatment for Multiple Sclerosis (Press)

India

  • Indian Health ministry declines to amend laws to define role of State Licensing Authorities' in monitoring clinical trials (PharmaBiz)

Japan & China

  • Beijing FDA Introduces New Regs On Advertisements For Drugs, Devices, And Dietary Supplements (PharmAsia-$)

Other International

  • WHO Mulls 'Biological Qualifier,' Separate From INN, For Biosimilars (IHP-$)
  • Australia Unveils Adverse Event Reporting Pilot for Medical Software (TGA)
  • Drug Patent Threat Opens Division on How to Fight Back (Bloomberg)
  • Merck Announces Canadian Approval of GRASTEK (Standardized Allergenic Extract, Timothy Grass (Phleum pratense) Sublingual Tablet) (Press)

General Regulatory And Interesting Articles

  • Pharma Companies Increase Cross-Functional Communication with Regulatory Affairs Teams (Cutting Edge)

Regulatory Reconnaissance #248 - 3 February 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.


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