Regulatory Focus™ > News Articles > Regulatory Recon: FDA Panel Calls for More Restrictive Codeine Labeling (11 December 2015)

Regulatory Recon: FDA Panel Calls for More Restrictive Codeine Labeling (11 December 2015)

Posted 11 December 2015 | By Michael Mezher 

Regulatory Recon: FDA Panel Calls for More Restrictive Codeine Labeling (11 December 2015)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher, @Zachary Brennan and @RAPSorg on Twitter.

In Focus: US

  • Device Used in Trial That Was Overseen by FDA Nominee Is Linked to Thousands of Reports of Injuries and Malfunction, Public Citizen Analysis Shows (Public Citizen)
  • J&J, Alphabet aim for smarter, smaller, cheaper surgical robot (Reuters)
  • FDA Panel Urges Stronger Regulation of Codeine (MedpageToday) (NPR)
  • FDA approves Otonomy's ear drug (Reuters) (Press)
  • US sales of antibiotics for food animals rose over six years (Reuters) (FDA)
  • Expect Intellectual Fireworks At FDA Advisory Panel On Ezetimibe (CardioBrief)
  • What We Mean When We Talk About Data (FDA Voice)

In Focus: International

  • Waking up to the realities of drug-resistant tuberculosis in children (The Hill)
  • New Superbug Resistant To All Antibiotics Linked To Imported Meat (Forbes)
  • Health Canada Readies Transition Plan for Full MDSAP Implementation (Emergo)
  • Global Harmonization Of Combination Product Regulation: EU vs US (Clinica-$)
  • Russia may refuse from further imports of Turkish drugs (PharmaLetter-$)
  • Global insulin majors may lose Russian market due to new state monopoly (PharmaLetter-$)

US: Pharmaceuticals and Biotechnology

  • GDUFA regulatory priorities for 2016 include complex drugs (GaBI)
  • NORD gets FDA grant for natural history studies (BioCentury) (Press)
  • Unlocking my genome: Was it worth it? (CNBC)
  • How AIDS Advocates Led the Way for PDUFA (Campaign for Modern Medicines)
  • Still in a Crib, Yet Being Given Antipsychotics (NYTimes)
  • Is Amgen's Prolia A Better Drug For Reducing Fractures And Recurrence After Breast Cancer? (Forbes)
  • Making waves: scientists use seaweed to grow stem cells (BioPharma-Reporter)
  • After the genome, AstraZeneca taps 'secretome' for novel drugs (Reuters)
  • FDA panel to discuss CV benefit of Vytorin, Zetia (BioCentury)
  • Seven Habits Of Celgene's Highly Successful Strategy (Forbes)
  • All I want [From FDA] for Christmas is ... (DrugWonks)
  • Don't Go With Your Gut When Thinking About Vaccines (MedpageToday)

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

  • Puma's once-vaunted cancer drug dogged by side effects in Phase II results (FierceBiotech)
  • Merck's IMPROVE-IT Study: Will Missing Data, Subgroups Hinder Zetia CV Claim? (PinkSheet-$)
  • Puma Biotechnology Presents 3-Year Disease Free Survival Data from Phase III Trial of PB272 in Extended Adjuvant Breast Cancer (ExteNET Trial) at the 2015 San Antonio Breast Cancer Symposium (Press)
  • First Ever Vaccine for Ovarian Cancer Granted Orphan Drug Status (MPR)
  • Teligent, Inc. Announces FDA Approval Of CEFOTAN (cefotetan) For Injection (Press)
  • After failing a PhII/III, Raptor steers Huntington's drug into a pivotal trial (FierceBiotech)
  • Roche adds another positive snapshot for its PD-L1 checkpoint star 'atezo' (FierceBiotech)
  • Prime-boost H7N9 influenza vaccine concept promising in clinical trial (MNT)
  • NuSirt Biopharma Receives FDA Fast Track Designation for Non-Alcoholic Fatty Liver Disease Treatment (Press)

`US: Medical Devices

  • MDUFA IV Negotiations: FDA, Industry Propose New Performance Goals (Focus)
  • Medtronic Announces FDA Approval of Infuse® Bone Graft for Three New Spine  (Medtronic)
  • Genentech Betting on a Device Approach to a Blockbuster Ophthalmic Drug (MDDI)
  • CareFusion wins dual FDA 510(k) for vertebral balloons (MassDevice)
  • Blood test that could predict arthritis risk (MNT)
  • Looking to a backup gene to fight spinal muscular atrophy (MassDevice)

US: Assorted and Government

  • New House Bill Seeks to Allow HHS to Negotiate Medicare Drug Prices (Focus)
  • White House: Opioid And Heroin Overdoses Are On The Rise (Forbes)
  • Congress Ignores The Real Prescription Drug Problem (DrugWonks)
  • Another Zoloft Daubert Win: How Many Strikes Before The Plaintiffs Are Out? (Drug and Device Law)
  • GPhA responds to Senate generics hearings (DSN)
  • The Ever-Expanding Biosimilar Labeling Debate – Institutional Investors Offer their Opinion and Request FDA to Hold a Hearing (FDA Law Blog)
  • Only 3 Congressmen Showed For A Hearing On The No. 1 Infectious Killer In The World (Huffington Post)
  • J&J Challenges Risperdal Penalty As First Amendment Violation (Pink Sheet-$)
  • Philly Jury Urged To Find Against J&J In Breast-Growth Case (Law360-$)
  • AstraZeneca Says Amneal Infringed Diabetes Drug Patents (Law360-$)
  • Gilead Pushes Court To Invalidate 2 Merck Drug Patents (Law360-$)
  • DC Circ. Tosses Watson's Appeal Of Vascepa FDA Remand (Law360-$)

Upcoming Meetings and Events              


  • Contraceptive implants linked with repeat abortions (OnMedica)
  • Pharma pollution is overlooked cause of antimicrobial resistance (EurActiv)
  • Discount And Rebates Fail To Sway NICE On Janssen's Zytiga (SCRIP-$)Elipse, a Swallowable, Procedureless Gastric Balloon for Weight Loss Cleared in Europe (medGadget)
  • NICE To Recommend AZ's Lynparza After All (SCRIP-$) (PharmaTimes)
  • Novartis earns provisional NICE yes for Entresto (Pharmafile)
  • Open Letter from EFPIA, AESGP and EGA Addressing the Public Debate Regarding Pharmaceuticals in the Environment, Antimicrobial Resistance and the Manufacturing Aspect (EFPIA)
  • Window Into HTA: Planning A Resource-Effective Strategy (Clinica)


  • Shortage of inspectors will hit fortunes of India's pharma companies (Times of India)
  • Sharon receives EIR report from USFDA on inspection closure (Economic Times)
  • India's Kumar says he's hard at work on pharma, medical devices ministry (FiercePharmaAsia)
  • Regulation and uptake of 'similar biologics' in India (GaBI)
  • Suven Life Sciences gets patent for neuro-degenerative drug (Economic Times)
  • Gilead Sciences to establish its first plant in Pharma City in Hyderabad (PharmaBiz)
  • Medical devices to be delinked from pharma industry soon (The Hindu)


  • cFDA announces big regulatory policy changes in China (EPR)


  • MHLW Approves Partial Label Change for Egg-White Lysozyme Preparation Neuzym (Press)


  • Over-the-counter topical acne products containing either BENZOYL PEROXIDE or SALICYLIC ACID - Assessing the potential risk of serious allergic reactions (Health Canada)


  • ACSMD meeting statement, Meeting 10, 26 August 2015 (TGA)
  • Consultation: Proposed amendments to the Poisons Standard (Codeine) (TGA)

Other International

  • First Step for a Dreadful Disease: Get on the List (Global Health Now)
  • Approval for Merck's Keytruda a political football in New Zealand (FiercePharmaAsia)
  • Bangladesh again noted for dominant domestic drug manufacture (FiercePharmaAsia)
  • Sickle cell: Nigeria stops commercial sale of Niprisan (The News)
  • Nigeria Has Capacity to Produce Anti-retroviral Drugs Locally (PharmaAfrica)

General Health and Other Interesting Articles

  • It's Time For Fairness In Organ Distribution (Health Affairs Blog)
  • Ghost Hearts and Biohacked Insulin: A Day at Counter Culture Labs (medGadget)
  • Using Public Surveillance to Study Insect Vectors of Chagas Disease in Texas (ICT)
  • Scientists Learn How Poxviruses Defeat the Body's Host Defense (ICT)

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 @Michael_Mezher or send him an email at

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.

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