Regulatory Focus™ > News Articles > Regulatory Recon: Some Drugs Still Being Marketed Despite Bioequivalence Concerns (17 June 2015)

Regulatory Recon: Some Drugs Still Being Marketed Despite Bioequivalence Concerns (17 June 2015)

Posted 17 June 2015 | By

Regulatory Recon: Some Drugs Still Being Marketed Despite Bioequivalence Concerns (17 June 2015)

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

In Focus: US

  • Generic ADHD Drug, Not Equivalent to the Brand, Is in Use Anyway (NYTimes)
  • Regulators asked to consider ageing as a treatable condition (Nature)
  • FDA Drugs Field Staff May Be Based In Four Offices After Realignment (Pink Sheet-$)
  • Can Expanding FDA's 'Breakthrough' Program Be An Answer To High Drug Costs? (Pink Sheet-$)
  • Are Things Really Picking Up in Drug R&D? (InThePipeline) (Nature)
  • District Court Rules for FDA in Battle Over the Scope of 3-Year Exclusivity (FDA Law Blog)
  • FDA to Hold Public Meeting on MDUFA Next Month (FDA) (Gray Sheet-$)
  • Senators Circulate Plan For Standalone FDA Diagnostics Center, 'In Vitro Clinical Test' Rules (Gray Sheet-$)
  • FDA Increasing Staffing in China, India (FDAnews-$)
  • Margaret A. Hamburg, MD, Reflects on 6 Years at FDA (JAMA)

In Focus: International

  • EU approves Sanofi's new Gardasil jab (PharmaTimes) (EC)
  • More on scrutiny in the general approach proposals for medical devices and IVDs (MDL)
  • EU trade secret proposals could help pharma avoid publishing trial results says NGO (In-Pharma)
  • Reflection paper on GCP compliance in relation to trial master files (paper and/or electronic) for management, audit and inspection of clinical trials (EMA)
  • Into the future: a single EU body assessing relative effectiveness of medicines? (Clinica-$)
  • Deputy at China agency that probed GSK arrested for corruption, report says (Fierce)
  • ICH Plans to Update M1 Points to Consider Document (ICH)

US: Pharmaceuticals and Biotechnology

  • Generic ADHD Drug, Not Equivalent to the Brand, Is in Use Anyway (NYTimes)
  • Regulators asked to consider ageing as a treatable condition (Nature)
  • FDA Drugs Field Staff May Be Based In Four Offices After Realignment (Pink Sheet-$)
  • Can Expanding FDA's 'Breakthrough' Program Be An Answer To High Drug Costs? (Pink Sheet-$)
  • Are Things Really Picking Up in Drug R&D? (InThePipeline) (Nature)
  • District Court Rules for FDA in Battle Over the Scope of 3-Year Exclusivity (FDA Law Blog)
  • Lawmakers: 'Cures' bill won't sacrifice US drug safety (SCRIP-$)
  • Top Class I drug recallers (Fierce)
  • Black Box Warning for Potiga Reviewed Again by FDA (MPR) (FDA)
  • Diabetes drug analysis flags heart failure, pancreatitis reports (Fierce)
  • The High Court's Impact On Drug Disposal Ordinances (Law 360-$)
  • North Carolina Senate Committee Approves Right to Try Act (Press)

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

  • Aerie Pharma shares soar as FDA lowers the hurdle for PhIII (Fierce) (BioCentury)
  • Chiasma Submits Octreotide NDA for Acromegaly (MPR)
  • UCB's Neupro meets in Chinese Phase III PD trial (BioCentury)
  • Ischemic Chronic Heart Failure Drug Fast Tracked by FDA (MPR)
  • Tonix Pharmaceuticals Announces Conditional Acceptance of Tonmya as Proposed Brand Name for Cyclobenzaprine HCl Sublingual Tablets, 2.8 mg (Press)

US: Pharmaceuticals and Biotechnology: General

  • ​Ex-Homeland Security cyber chief warns of threats to pharma (Outsourcing Pharma)
  • Global Prescription Drug Sales Forecast to Reach $987B by 2020 (Pharmalot)
  • Pharma R&D Pipeline Value Jumps 18 Percent to $493 Billion (BIO)
  • New White Paper from BIO, NORD, and EY Finds Orphan Drug Tax Credit is Crucial to Rare Disease R&D (Press)

US: Medical Devices

  • FDA to Hold Public Meeting on MDUFA Next Month (FDA) (Gray Sheet-$)
  • Senators Circulate Plan For Standalone FDA Diagnostics Center, 'In Vitro Clinical Test' Rules (Gray Sheet-$)
  • Content and Format of Abbreviated 510(k)s for Early Growth Response 1 Gene Fluorescence In-Situ Hybridization Test System for Specimen Characterization Devices (FDA)
  • Meetings: Non-Microbial Biomarkers of Infection for In Vitro Diagnostic Device Use (FDA)
  • FDA Classifies Heartware Recall as Class I (FDA)
  • Breathe Technologies, Inc. announces FDA clearance for Life2000 Ventilation System (Press)

US: Dietary Supplements

  • Time for DSHEA 2.0? (NPI)

US: Assorted And Government

  • FDA Increasing Staffing in China, India (FDAnews-$)
  • Margaret A. Hamburg, MD, Reflects on 6 Years at FDA (JAMA)
  • Upton aiming for 80% of House to back 21st Century Cures (ModernHealthcare)
  • House leaders push back on criticism of cures bill (The Hill)
  • House Ag/FDA Appropriations Mark-up Scheduled for June 18 (StrengthenFDA)
  • W&M May Decide Wednesday Whether To Ax Medicare Measures In Cures Bill (IHP-$)

Upcoming Meetings and Events

Ebola Outbreak

  • Ebola vaccines in limbo expose need for more speed in trials (Reuters)

Europe

  • EU approves Sanofi's new Gardasil jab (PharmaTimes) (EC)
  • More on scrutiny in the general approach proposals for medical devices and IVDs (MDL)
  • EU trade secret proposals could help pharma avoid publishing trial results says NGO (In-Pharma)
  • Reflection paper on GCP compliance in relation to trial master files (paper and/or electronic) for management, audit and inspection of clinical trials (EMA)
  • Into the future: a single EU body assessing relative effectiveness of medicines? (Clinica-$)
  • 'Lack of trust' in medicines prompts UK review (SCRIP-$)
  • Alcon gets CE mark to sell new intraocular lens in Europe (Fierce)
  • Masimo wins CE Mark for Root with BP & temp sensor (MassDevice)

India

  • Rampant fraud at medical schools leaves Indian healthcare in crisis (Reuters)

China

  • Deputy at China agency that probed GSK arrested for corruption, report says (Fierce)

Canada

  • Health Canada requests quarantine of drugs linked to Zhejiang Hisun Pharma due to data integrity concerns (HC)
  • Notice: Interim Policy on Health Canada's Interpretation of Medicinal Ingredient (HC)

Australia

  • Recall for Philips Devices That Use Auto Servo Ventilation Therapy (TGA)

Clinical Trials

Other International

  • ICH Plans to Update M1 Points to Consider Document (ICH)
  • ICH Plans Implementation of MedDRA Version 19.0 (ICH)

General Regulatory And Interesting Articles

  • GlaxoSmithKline budgets $95M to launch a 'living genome' drug research institute (Fierce) (Forbes)

Regulatory Reconnaissance #577 – 17 June 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.


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