Regulatory Focus™ > News Articles > Regulatory Reconnaissance (26 September 2013)

Regulatory Reconnaissance (26 September 2013)

Posted 26 September 2013 | By Alexander Gaffney, RAC

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Tips? Gripes? Let me know: news@raps.org.

Note: Your news editor is back in the office after spending three days at the AdvaMed 2013 conference. Lots of extremely important news to write about this morning, so check back often today.

In Focus: US

  • FDA blasts ANDA Citizen's Petitions (BioCentury) (FDA Law Blog)
  • Another Fresenius plant gets warning letter (Fierce)
  • Per FDASIA, FDA Releases New MAPP on Responding to ANDA Inquiries (FDA)
  • Dozens of Currently Available Dermatology Mobile Apps May Fall Outside FDA's "Enforcement Discretion" Safe Harbor (Pharma Marketing)
  • FDA distributes $3.5M to spark pediatric device development (Fierce)
  • Regulators prepare to be 'handcuffed' in government shutdown (The Hill)

In Focus: International

  • Canada urged to accept US, EU drug approvals (Pharma Times) (Report)
  • EMA Adopts ICH S1 Guideline on Rodent Carcinogenicity Testing (EMA)
  • Evidence Growing That Drug Counterfeiters Are Targeting Generics In The EU (Pink Sheet-$)
  • European Medicines Agency organising workshop on biosimilars (EMA)
  • FDA warning points to infrastructure issue in India (Fierce)
  • Biocon Chief Hints In Tweet Firm Would Quit India Over Regulatory Delays (PharmAsia-$)

Comments? Suggestions? Email me at news@raps.org.

US: Pharmaceuticals/Biotechnology

  • FDA blasts ANDA Citizen's Petitions (BioCentury) (FDA Law Blog)
  • Another Fresenius plant gets warning letter (Fierce)
  • Boxed Warning of HBV Risk Added to Rituxan, Arezerra (MedPage Today) (FDA)
  • Nine Ideas to Make Tylenol and Other Acetaminophen Drugs Safer (ProPublica)
  • Per FDASIA, FDA Releases New MAPP on Responding to ANDA Inquiries (FDA)
  • Sanofi justifies decision to withdraw US filing for Lyxumia (PMLive)
  • Sunscreen for babies, kids recalled for potential contamination (NBC)
  • FDA Vs.Stanislaw Burzynski, Again: His IRB Fails Another Inspection (Pharmalot)
  • Conflicting goals between the FDA and Congress are creating an interesting "tug of war" across the Generics space (PharmaManufaturing)
  • J&J Urges Switch To Sun's Doxil Generic If U.S. Supplies Run Out (PharmAsia-$)
  • Lumena Pharmaceuticals Receives Orphan Drug Designation from US Food & Drug Administration for LUM001 in Four Rare Liver Diseases (Press)
  • AMAG dives on FDA notice of deficiencies with Feraheme sNDA (SCRIP-$) (BioFlash)
  • Drug Comparison Suits May Drive Shift In Pharma Ads (Law 360)
  • Increase In Deaths Linked To First Line Treatment With Sulfonylureas (Forbes)

US: Pharmaceuticals and Biotechnology: General

  • Pfizer/Meridian win $60m BARDA contract for nerve agent countermeasure (SCRIP-$)
  • Gene Patenting, the Supreme Court's Myriad Decision, and the Future of Biotechnology (Harvard)

US: Medical Devices

  • Dozens of Currently Available Dermatology Mobile Apps May Fall Outside FDA's "Enforcement Discretion" Safe Harbor (Pharma Marketing)
  • FDA distributes $3.5M to spark pediatric device development (Fierce)
  • Deloitte's 4 medical device security threats (GHIT)
  • 'Stupid' medical device tax faces GOP repeal (Fierce)
  • Nit-Occlud PDA for Fixing Patent Ductus Arteriosus Cleared in U.S. (MedGadget)
  • Nu Skin Obtains FDA Clearance of Facial Spa Device (Press)
  • Actuated Medical's TubeClear System Receives Additional FDA Clearance - Can Now Be Used for NE, NG, G and J Feeding Tubes (Press)

US: Assorted And Government

  • FDA and Social Media Do's and Don'ts Based on Warning Letters, Waiting for July 2014 Guidance? (Policy and Medicine)
  • Regulators prepare to be 'handcuffed' in government shutdown (The Hill)
  • If ex-Intermune CEO's conviction goes to the Supreme Court, who wins? (Fierce)
  • Pfizer Tracking Spiked Supplements With FDA, Enforcement Agencies (Pink Sheet-$)
  • USA Today: Mexican company selling adulterated dietary supplements can't be found (DSN)
  • Enforcement Report - Week of September 25, 2013 (FDA)

Upcoming Meetings And Events

  • 24 September 2013: Public Meeting on Narcolepsy Patient-Focused Drug Development (FDA)
  • 25-26 September 2013: ENVI Meeting on Medical Device Proposals (ENVI)
  • 25-26 September 2013: FDA Small Business Regulatory Education for Industry Conference (FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

  • EMA Adopts ICH S1 Guideline on Rodent Carcinogenicity Testing (EMA)
  • Evidence Growing That Drug Counterfeiters Are Targeting Generics In The EU (Pink Sheet-$)
  • European Medicines Agency organising workshop on biosimilars (EMA)
  • NICE endorses breast cancer treatment test (Pharma Times)
  • EC approves Gilead's Tybost HIV boost (BioCentury) (Press)
  • EC approves Boehringer's Giotrif for NSCLC (BioCentury)
  • NICE's Dillon: Value-based pricing deadline 'very tight' (SCRIP-$)
  • Working parties for healthcare professionals and for patients and consumers elect new co-chairs (EMA)
  • UK Universities called upon to improve reporting of animal research (NC3Rs)
  • Abbott's FreeStyle Optium Neo Glucometer and Ketone Monitoring System CE Marked (MedGadget)

Asia

  • FDA warning points to infrastructure issue in India (Fierce)
  • Biocon Chief Hints In Tweet Firm Would Quit India Over Regulatory Delays (PharmAsia-$)
  • MHLW Japan Approves 15 New Drugs Including Three Combinations For Respiratory Disease (PharmAsia-$)
  • Pakistan Drafts Restrictions On Drug Industry Conferences, Doctor Gifts (PharmAsia-$)

Other International

General Regulatory And Interesting Articles

  • Insight: How new cancer drugs can skip randomized trials (Reuters)
  • Mathematical model aims to reduce reactions to implanted devices (Fierce)
  • Robots vs. Anesthesiologists (WSJ)
  • First Bionic Leg Allows Mind to Control Movement in Study (Bloomberg)
  • A 'Silver Bullet' Cancer Drug ... For Five Mice, That Is! (MedPage Today)
  • 3-D-printed prosthetic made for band student (CBS)
  • Researchers use nanoparticles to deliver vaccines to lungs (Press)

Regulatory Reconnaissance #164 - 26 September 2013

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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