Regulatory Focus™ > News Articles > Regulatory Reconnaissance (22 November 2013)

Regulatory Reconnaissance (22 November 2013)

Posted 22 November 2013 | 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

  • In tense hearing, congressman declares "software is not a medical device" (MobiHealthNews) (Mass Device)
  • FDA Doubles Estimated Time Needed For DMF Completeness Assessment (Pink Sheet-$)
  • Amarin's ANCHOR Appeal Shot Down by FDA on "Procedural Grounds" (Press) (Reuters)
  • Combination Products: Everyone Wants to Be a Device (RPM Report-$)
  • How FDA Will Use Its New Authority against Denying, Limiting or Refusing Inspections - And Why Industry is Still Worried (Gold Sheet-$)
  • Are Cleanrooms Clean? Human Microbiome Project Raises Some Questions (Gold Sheet-$)

In Focus: International

  • Indian Manufacturer Biocon Obtains Approval for Biosimilar Herceptin (India Times)
  • China Looks To Amend Drug Registration Regulation With Bolar Exemption That Favors Generics (PharmAsia-$)
  • UK govt unveils rare diseases strategy (Pharma Times) (PMLive) (UK Gov)
  • Device Regulations In Europe 80% Baked In Even if Not Formally Adopted (MDDI)
  • EMA Approves New Drugs, Including AZ's Xigduo, Janssen's Invokana, Celgene's Abraxane, Novo Nordisk's NovoRapid (Press) (Press) (Press) (Pharma Letter-$)

US: Pharmaceuticals/Biotechnology

  • FDA Doubles Estimated Time Needed For DMF Completeness Assessment (Pink Sheet-$)
  • Amarin's ANCHOR Appeal Shot Down by FDA on "Procedural Grounds" (Press) (Reuters)
  • Latest Reolysin data 'confound' Oncolytics investors (SCRIP-$) (Reuters) (Forbes) (Fierce)
  • Sanofi, Regeneron arthritis drug meets goals in Phase 3 trial (Reuters) (Pharma Times) (PMLive) (Fierce)
  • Senators: Compounding Bill Not Meant To Limit Drug Access, States' Rights (IHP-$)
  • Novartis chases Pfizer in hot new breast cancer drug area (Reuters)
  • Risperdal Settlement Shows False Claims Act Prosecutions Still Have Teeth AfterCaronia (RPM Report-$)
  • Pfizer and GSK link up to trial combo melanoma therapy (Pharma Letter-$) (SCRIP-$) (PMLive)
  • Using FDA Big Data and Electronic Health Records to Improve Drug Safety (Policy and Medicine)
  • DQSA: Will U.S. Pharma Distributors Mandate Aggregation Data In Phase 1? (RxTrace)
  • New Side-Effect of Pfizer's Xalkori Identified (DD&D) (Press)
  • Knowledge and Intended Use (Drug and Device Law)

US: Pharmaceuticals and Biotechnology: General

  • Together Rx Patient Assistance Program Will Close When ACA Coverage Expansion Begins (Pink Sheet-$)
  • GS1 ratifies new EPC standard for RFID (Securing Industry)

US: Medical Devices

  • In tense hearing, congressman declares "software is not a medical device" (MobiHealthNews) (Mass Device)
  • Combination Products: Everyone Wants to Be a Device (RPM Report-$)
  • Hospira Issues Class 1 Recall for 50,000 Gemstar Infusion System (FDA) (FDA)
  • GE Healthcare lands FDA approval for Optison contrast agent (Mass Device)
  • GE Oslo plant gets FDA OK for new heart imaging product (Fierce)
  • Cohera completes PMA application for surgical adhesive (Mass Device)

US: Dietary Supplements

  • GMP Inspectors Zero In On Contaminants, "Goodness" Of Basic Tests (Tan Sheet-$)
  • OxyElite Pro User Sues USPlabs, GNC (NPI)
  • Hi-Tech sues FDA over 'bullying campaign' (Nutra Ingredients)
  • The next 2-3 years will see a huge shift towards DNA barcoding for botanicals: AuthenTechnologies CEO (Nutra Ingredients)

US: Assorted And Government

  • How FDA Will Use Its New Authority against Denying, Limiting or Refusing Inspections - And Why Industry is Still Worried (Gold Sheet-$)
  • FDA Provides More Information on Why its Veterinary AdComm Disbanded (FDA)
  • CMTP names heads of trial standards consortia (BioCentury)
  • Surgeon General-Nominee Murthy Would Bring Clinical Trial Experience To Post (Pink Sheet-$)

Upcoming Meetings And Events

  • 2-3 December 2013: AHWP/RAPS Joint Conference in Malasia (RAPS)
  • 9 December 2013: Joint Meeting of the Gastrointestinal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee (FDA)
  • 11 December 2013: Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee (FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

  • UK govt unveils rare diseases strategy (Pharma Times) (PMLive) (UK Gov)
  • EMA recommends restricting use of thiocolchicoside by mouth or injection (EMA)
  • Device Regulations In Europe 80% Baked In Even if Not Formally Adopted (MDDI)
  • INVOKANA (canagliflozin) Approved in the European Union for Treatment of Adults with Type 2 Diabetes (Press)
  • Xigduo (dapagliflozin and metformin hydrochloride) receives positive CHMP opinion in the European Union for the treatment of type 2 diabetes (Press)
  • Celgene Receives Positive CHMP Opinion for ABRAXANE in Combination with Gemcitabine as Treatment for Patients with Metastatic Pancreatic Cancer (Press)
  • EMA Committee backs Novo Nordisk's NovoRapid PumpCart (Pharma Letter-$)
  • All Applications Currently Before EMA (EMA)
  • AB Science Shares Plunge as EU Panel Fails to Back Cancer Drug (Bloomberg)
  • EMA to review Fibrocaps (BioCentury)
  • EU Parliament approves Horizon 2020 (BioCentury)
  • UK medicines regulator slams door on herbal food supplements (Nutra Ingredients)

Asia

  • Indian Manufacturer Biocon Obtains Approval for Biosimilar Herceptin (India Times)
  • China Looks To Amend Drug Registration Regulation With Bolar Exemption That Favors Generics (PharmAsia-$)
  • Avastin ovarian cancer approval a first for Japan (SCRIP-$)
  • Bayer receives new approval for Eylea eye treatment in Japan (Reuters) (Press)
  • AHWP Calls for Comments on Several Rule Changes (AHWP) (AHWP) (AHWP)

Other International

  • Australia Issues Safety Advisory over Mis-Marked Baby Drops Syringe (TGA)

General Regulatory And Interesting Articles

  • Are Cleanrooms Clean? Human Microbiome Project Raises Some Questions (Gold Sheet-$)
  • Regulatory costs will rise, fines will increase, expert warns (Outsourcing Pharma)
  • Three Cancer Drugs Don't Work Properly Without Gut Bacteria (NatGeo)
  • Genetic Testing Leaves More Patients Living in Limbo (WSJ-$)

Regulatory Reconnaissance #208 - 22 November 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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