Regulatory Focus™ > News Articles > Regulatory Recon: Canada's Drug Approval Secrecy Under Fire (19 January 2015)

Regulatory Recon: Canada's Drug Approval Secrecy Under Fire (19 January 2015)

Posted 19 January 2015 | By

Regulatory Recon: Canada's Drug Approval Secrecy Under Fire (19 January 2015)

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

In Focus: US

  • FDA green light for AbbVie's PD drug Duopa (PharmaTimes) (Press)
  • 2014 505(b)(2) NDA Approvals (Camargo)
  • Accelerated Approval Labeling Changes Take Shape In Recent Approvals (Pink Sheet-$)
  • The Education Of ODAC: How Sandoz Made Its Case For Biosimilarity (Pink Sheet-$)
  • FDA Webinar: Getting Ready for GUDID (Registrar Corp)
  • Highlights from FDA's Workshop on Proposed Framework for LDTs (JDsupra)
  • Congressional Research Service Weighs in on LDT Regulation (CRS)
  • Federal judge approves consent decree with California dietary supplement maker (FDA)

In Focus: International

  • Why so much secrecy when it comes to drug approval, Health Canada? (Globe and Mail)
  • A baptism of fire for Europe's new health commissioner (PMLive)
  • Boehringer: OFEV (nintedanib) approved in the EU for the treatment of IPF (Press) (Pharmafile) (Pharmatimes)
  • Regulating mHealth in the EU: Medical Devices Directive plus a new certification scheme? (Clinica-$)
  • Can Obama And Modi Settle The US-India Feud In The Pharmaceuticals Sector? (IBTimes)
  • China tightens administration of medical instruments (Xinhua)

US: Pharmaceuticals and Biotechnology

  • FDA green light for AbbVie's PD drug Duopa (PharmaTimes) (Press)
  • 2014 505(b)(2) NDA Approvals (Camargo)
  • Accelerated Approval Labeling Changes Take Shape In Recent Approvals (Pink Sheet-$)
  • FDA 2014 NDA Approvals – The Surge of the Niche Products – Good or Bad? (Camargo)
  • GPhA Supports Appointment of Kathleen Uhl to OGD Director Position (Press)
  • FDA Withdraws Bioequivalence Recommendation for Oral Budesonide (FDA)
  • Fresenius Kabi Receives FDA Approval for Neostigmine Methylsulfate Injection (Press)
  • Can we use social media to support content validity of patient-reported outcome instruments in medical product development? (PubMed)
  • The Education Of ODAC: How Sandoz Made Its Case For Biosimilarity (Pink Sheet-$)
  • Neupogen Off-Label Use Complicates Data Extrapolation For Sandoz’s Biosimilar (Pink Sheet-$)
  • Is Sandoz Filgrastim For Real? FDA Panel Presentation Nearly Philosophical (Pink Sheet-$)
  • Florida "Right to Try" Bill Introduced (Press)
  • Kansas "Right to Try" Bill Introduced (CJonline)
  • 'Biosimilars' law returns to Colorado Legislature; would allow generics to be swapped for biotech drugs (BizJournal)
  • FDA Rejects Suitability Petition for Veterinary Drug Tergive Carprofen (FDA)
  • Changing Face Of ‘Me Too’ Drugs On Display In 2014 NME Approvals (Pink Sheet-$)

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

  • Merck funds tests of lower Zilmax doses as seen seeking way to resume sales (Reuters)
  • Amgen: Phase 2/3 Study Data Announced for Vectibix in Colorectal Cancer (MPR)
  • Neurocrine Biosciences Announces Granting of Orphan Drug Status for NBI-77860 in Congenital Adrenal Hyperplasia (Press)

US: Pharmaceuticals and Biotechnology: General

  • NIH study reveals many Americans at risk for alcohol-medication interactions (NIH)
  • Did Express Scripts Choose the Right Hepatitis C Drug? A Look at Safety (AdverseEvents)
  • Timing or economics? US vulnerable after flu vaccine mismatch (SCRIP-$)

US: Medical Devices

  • FDA Webinar: Getting Ready for GUDID (Registrar Corp)
  • Highlights and Commentary from the FDA's Public Workshop on Proposed Framework for Regulatory Oversight of Laboratory Developed Tests (JDsupra)
  • Congressional Research Service Weighs in on LDT Regulation (CRS)
  • Flowonix Medical Inc. Announces FDA PMA(S) Approval of Prometra II (Press)
  • February 20 Meeting of the Orthopaedic and Rehabilitation Devices Panel (FDA)
  • BiO2 Medical wins FDA nod for pivotal trial of Angel IVC catheter (Mass Device)

US: Dietary Supplements

  • Federal judge approves consent decree with California dietary supplement maker (FDA)
  • Warning letter cites NDI status of magnesium ingredient but doesn't raise safety concern (NI-USA)

US: Assorted And Government

  • Obama, Cameron declare trade, Ebola among priorities (SCRIP-$)
  • U.S. developing large-scale genomics project (BioCentury)
  • Enforcement Report - Week of January 14, 2015 (FDA)

Upcoming Meetings

Europe

  • Regulating mHealth in the EU: Medical Devices Directive plus a new certification scheme? (Clinica-$)
  • A baptism of fire for Europe's new health commissioner (PMLive)
  • Boehringer: OFEV (nintedanib) approved in the EU for the treatment of IPF (Press) (Pharmafile) (Pharmatimes)
  • Novartis' first-in-class psoriasis drug approved in Europe (PharmaPhorum)
  • MHRA Warns About Accu-Check Insulin Pumps (MHRA)
  • Celgene: Oral OTEZLA (apremilast) Approved by the European Commission for the Treatment of both Patients with Psoriasis and Psoriatic Arthritis (Press)
  • EM's CVMP Recommends New Veterinary Drugs (EMA)

India

  • Can Obama And Modi Settle The US-India Feud In The Pharmaceuticals Sector? (IBTimes)
  • MNCs recall drugs made in Indian plants (DNAindia)
  • D&C Amendment Bill proposes to make DTAB notified authority (PharmaBiz)
  • Insight On India – Highlights From The Week Of Jan 11-17, 2015 (Two-Four Insight)
  • Could a surgeon become DCG(I)? (Express Pharma) (PharmaBiz)
  • Drug controller booked for amassing disproportionate assets (ZeeNews)

China

  • China tightens administration of medical instrument (Xinhua)

Canada

  • Why so much secrecy when it comes to drug approval, Health Canada? (Globe and Mail)
  • Canadian Apotex facility flagged for problems (The Star)

Australia

  • Medical Devices Safety Update, Volume 3, Number 1, January 2015 (TGA)

Other International

  • International Generic Drug Regulators Programme (IGDRP) Information Sharing Pilot to be extended to generics authorised through the EU centralised procedure (TGA)

General Regulatory And Interesting Articles

Regulatory Reconnaissance #474 – 19 January 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:

[DataConnection.HandleError]: Query: SELECT [CategoryID], [CategoryName], [Icon], [CategoryCode] FROM RAPS_News_Category WHERE (DisplayOnFrontEnd=1 AND CategoryID IN(,397,395)) ORDER BY CategoryName ASC Caused exception: Incorrect syntax near ','.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe