Regulatory Focus™ > News Articles > Regulatory Recon: FDA Under Pressure to Finalize Opioid Guidance (19 March 2015)

Regulatory Recon: FDA Under Pressure to Finalize Opioid Guidance (19 March 2015)

Posted 19 March 2015 | By Alexander Gaffney, RAC 

Regulatory Recon: FDA Under Pressure to Finalize Opioid Guidance (19 March 2015)

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

In Focus: US

  • Congress Pressures FDA to Finalize Opioid Guidance (MedPage Today)
  • Wockhardt Says FDA Finds no Problems With Company Maharashtra Plant (NDTV) (India Times)
  • Why people with diabetes can't buy generic insulin (Press) (NPR) (NEJM) (CBS)
  • To sell or not to sell: United Therapeutics faces choice with potential fast-track drug voucher (BizJournal)
  • Oregon Introduces Pharmaceutical Price Transparency Bill (Policy and Medicine)
  • Deadly bacteria outbreak inflames disinfection concerns (USA Today)
  • CDRH—Feeling the Love? (MDDI)
  • FDA Software Validation: What To Do To Validate Quality Computer Systems (MBT)
  • Advancing Medical Innovation Through Public Policy (Bipartisan Policy Center) (Fierce)
  • Stakeholders aiming to renew pediatric voucher program (BioCentury)
  • Noninferiority Trial Reporting Falls Short (MedPage Today) (JAMA)

In Focus: International

  • FDA’s Hamburg Says EMA Could Be Model For Global Regulatory Coalition (Pink Sheet-$)
  • KEI Europe Asks Romanian Government To Issue Compulsory Licences On Hepatitis C Medicines (KEI)
  • England's Cancer Drugs Fund changes its tune, holds onto Novartis' Afinitor (Fierce)
  • Indian companies not singled out for inspections, says USFDA (India Times)
  • US FDA, DCG(I) explore more ways to work together (Express)
  • China Drug Approval Backlog Piling Up Fast (PharmAsia-$)
  • AstraZeneca sees the light on clinical trial transparency (PharmaTimes)

Learn About--and Help Shape--FDA's Draft Combo Products GMP Guidance

  • When it comes to combination products, more regulations can mean more difficulties for regulatory professionals. That's why we've teamed up with the Combination Products Coalition (CPC) to offer a full day interactive program focused on FDA's newest draft guidance on Good Manufacturing Practices (GMPs) for combination products. Learn from FDA experts and industry veterans in this unique experience that will help agency regulators to shape and clarify the final guidance document. You can register here.

US: Pharmaceuticals and Biotechnology

  • Congress Pressures FDA to Finalize Opioid Guidance (MedPage Today)
  • Wockhardt Says FDA Finds no Problems With Company Maharashtra Plant (NDTV) (India Times)
  • Why people with diabetes can't buy generic insulin (Press) (NPR) (NEJM) (CBS)
  • To sell or not to sell: United Therapeutics faces choice with potential fast-track drug voucher (BizJournal)
  • How the rushed biosimilar law is yielding go-slow launches (EP Vantage)
  • Texas Right to Try Bill Faces Skepticism (Statesman)
  • Right To Try Bill Passes North Dakota House and Senate (ValleyNews)
  • FDA Approval for Generic Celebrex (CNBC)
  • FDA updates Study Data Technical Conformance Guide (Exalon)
  • Pfizer takes issue with Little Remedies (MM&M)
  • Micro Labs recalls 54,096 bottles of cholesterol drug in US (India Times)
  • Skeptics speak out: Precision medicine may sound sexy, but is it overrated? (MedCityNews)

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

  • Sanofi on track to refile Lyxumia in US (PMLive) (PharmaLetter-$) (Sanofi)
  • Nektar hit by breast cancer trial setback (PMLive)
  • Study: Prevnar Vaccine Slashed Serious Infections in Elderly (AP)
  • Amicus Accelerates Approval Filing Plans for Rare Disease Drug (The Street)
  • Deep dive into Actelion's Uptravi data calms investors as FDA decision date nears (Fierce)
  • Sirtex Medical loses $1b in market value after cancer trial disappoints (SMH)
  • FDA grants Nicox orphan drug designation for naproxcinod in Duchenne muscular dystrophy (PharmaLetter-$) (Press)
  • Orphan Status Granted to Investigational Pulmonary Arterial Hypertension Drug (MPR)

US: Pharmaceuticals and Biotechnology: General

  • Oregon Introduces Pharmaceutical Price Transparency Bill; PhRMA and BIO Outline Serious Concerns To Oregon State Legislature During Public Hearing (Policy and Medicine)
  • DEA Issues Nationwide Alert on Fentanyl as Threat to Health and Public Safety (DEA) (Reuters) (WSJ-$)
  • Marijuana Gears Up for Production High in U.S. Labs (SciAm)
  • Risks Run High When Antipsychotics Are Prescribed For Dementia (NPR)
  • Risks of Opioid Use in the Elderly and Medicare Populations (Pew)
  • A child or teen poisoned by medicine almost every minute: report (Today)
  • Why Synthroid is the Most Prescribed Brand Medicine in the USA (Iodine)

US: Medical Devices

  • Deadly bacteria outbreak inflames disinfection concerns (USA Today)
  • CDRH—Feeling the Love? (MDDI)
  • FDA Software Validation: What To Do To Validate Quality Computer Systems (MBT)
  • PAD: Medtronic wins expanded FDA nod for Protégé GPS stent (MassDevice) (Press)
  • Medtronic steerable sheath recalled, deemed potentially deadly by the FDA (Fierce)
  • Semler Announces FDA Clearance for Next Generation PAD Testing System (Press)
  • American College of Cardiology meeting supportive of ablation to treat warning sign of stroke (Fierce)

US: Dietary Supplements

  • USPLabs Responds to Senate Letter Questioning Supplements (Press)

US: Assorted And Government

  • Advancing Medical Innovation Through Public Policy (Bipartisan Policy Center) (Fierce)
  • Stakeholders aiming to renew pediatric voucher program (BioCentury)
  • Noninferiority Trial Reporting Falls Short (MedPage Today) (JAMA)
  • Think tank: FDA needs better use of big data (GovHealthIT)
  • Drug and Device Makers are Being Hit With More Securities Fraud Lawsuits (Pharmalot)
  • FDA's Weekly Enforcement Report (FDA)
  • Outgoing FDA Commissioner Dr. Margaret Hamburg to Speak at National Press Club March 27 (Press)
  • The true cost of an arm and a leg (WaPo)

Upcoming Meetings and Events

Europe

  • FDA’s Hamburg Says EMA Could Be Model For Global Regulatory Coalition (Pink Sheet-$)
  • KEI Europe Asks Romanian Government To Issue Compulsory Licences On Hepatitis C Medicines (KEI)
  • England's Cancer Drugs Fund changes its tune, holds onto Novartis' Afinitor (Fierce)
  • EU safety logo set to tighten net on dodgy food supplement sales (In-Pharma)
  • PROFILE: Tomas Salmonson, chair of the EMA's CHMP (SCRIP RA-$)
  • Silver Bullet Therapeutics Announces CE Mark Approval for the OrthoFuzIon Cannulated Bone Screw System (Press)

India

  • Indian companies not singled out for inspections, says USFDA (India Times)
  • US FDA, DCG(I) explore more ways to work together (Express)
  • Drug Controller, Heal Thyself (Business Today)
  • "DCGI's Autonomy Is for the Government to Decide"- GN Singh (Business Today)

China

  • China Drug Approval Backlog Piling Up Fast (PharmAsia-$)

Other International

  • Sanofi R&D head bemoans divergence in global drug regulation (Reuters)
  • Charity attacks Gilead over hepatitis C drug restrictions (Reuters) (Fierce) (MSF) (PharmaBiz) (India Times)
  • KEI, KEI Europe, and Essential Inventions ask five companies for licenses to HCV patents (KEI)

Clinical Trials

  • Noninferiority Trial Reporting Falls Short (MedPage Today) (JAMA)
  • AstraZeneca sees the light on clinical trial transparency (PharmaTimes)
  • Pharma gets social: How Novartis is transforming clinical trials with social media (PharmaPhorum)
  • Research from IQWiG shows early benefit assessment increases trial data transparency (PharmaLetter-$)
  • Clinical Ink, CentrosHealth merge to bolster mobile clinical trial tools (MobiHealthNews)

General Regulatory And Interesting Articles

  • Google Filed A Patent For A Wearable To Zap Cancer (BuzzFeed)
  • Venture philanthropy deal-making: How and why foundations fund biopharma (FasterCures)

Regulatory Reconnaissance #517 – 19 March 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: Recon, Regulatory News

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