Regulatory Focus™ > News Articles > Regulatory Recon: SEC Warns Companies About Mischaracterizing FDA Communications (4 March 2015)

Regulatory Recon: SEC Warns Companies About Mischaracterizing FDA Communications (4 March 2015)

Posted 04 March 2015 | By Alexander Gaffney, RAC

Regulatory Recon: SEC Warns Companies About Mischaracterizing FDA Communications (4 March 2015)

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

In Focus: US

  • SEC warns pharma companies to be honest about FDA correspondence (Reuters) (SEC)
  • FDA Warns on Drugs to Treat Low Testosterone Levels in Men (FDA) (WSJ-$) (NYTimes) (AP) (Public Citizen) (Reuters) (NPR) (MedPage Today) (SCRIP-$) (Pink Sheet-$)
  • Orexigen Released Interim Data Without Approval Of Trial Leaders (Forbes) (Bloomberg) (Forbes) (The Street)
  • The FDA Is Forcing Orexigen To Do A Second Safety Study Because Of Contrave Disclosures (Forbes) (Forbes) (BioCentury) (SCRIP-$)
  • REMS Approval Letter Reads More Like A Scolding (Pink Sheet-$)
  • FDA: Manufacturer never had permission to sell device connected to superbug deaths (CNN)
  • How one Mobile App Maker got Clearance from FDA (QZ)
  • FDA Years-Long Crusade Against Supplement Firm Raises Questions About Enforcement (NPI)
  • Researchers find safety disclaimers do not register with consumers (MM&M)

In Focus: International

  • Patients should have a say in their medication, claims NICE (PMLive) (PharmaTimes)
  • The EMA at 20: A decade of expansion, collaboration and new legislation (SCRIP RA-$)
  • France Unveils New Update to its GMP Guidelines (ANSM)
  • India Guidance Would Make Sponsors Responsible for All Deaths in Trials (FDAnews-$)
  • Canada's New Manufacturing Warnings Page (Health Canada)

As the EU Gears up for Major Device Changes, What do Regulatory Pros Need to Know?

  • In Europe, medical devices currently are regulated much the same way they have been since the 1990s. Now, almost 20 years and several major scandals later, EU officials are preparing a massive overhaul of the region's medical device regulatory directives in the hopes of modernizing the system—if only they could agree on what those changes should look like. (Regulatory Focus)
  • Find out what changes are likely to affect medical devices and IVDs next year in this 11 March 2015 webcast featuring expert Erik Vollebregt. (RAPS Webcast)

US: Pharmaceuticals and Biotechnology

  • FDA Warns on Drugs to Treat Low Testosterone Levels in Men (FDA) (WSJ-$) (NYTimes) (AP) (Public Citizen) (Reuters) (NPR) (MedPage Today) (SCRIP-$) (Pink Sheet-$)
  • SEC warns pharma companies to be honest about FDA correspondence (Reuters) (SEC)
  • The Next Pharmaceutical Marketing Frontier: Your Medical Records (WSJ-$)
  • Why Aren’t Drug Companies Developing New Medicines To Stop Superbugs? (IBTimes)
  • REMS Approval Letter Reads More Like A Scolding (Pink Sheet-$)
  • Are Risk Evaluation and Mitigation Strategies Associated With Less Off-Label Use of Medications? The Case of Immune Thrombocytopenia (Wiley-$)
  • Variations in Time of Market Exclusivity Among Top-Selling Prescription Drugs in the US (JAMA-$)
  • Agency Withdraws Rules That Could Have Impacted Crop-Produced Pharmaceuticals (APHIS)
  • After counterfeit Avastin—what have we learned and what can be done? (Nature-$)
  • AMCP To FDA: Tread Carefully On Biosimilar Naming As Policy Will Drive Pharmacists' Decisions (IHP-$)
  • How much would it cost to ban antibiotic growth promoters in the livestock sector? (CDDEP)
  • FDA guidance documents change compounding landscape (BakerLaw)
  • Wyoming Right to Try Bill Advances (Scout)

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

  • Orexigen Released Interim Data Without Approval Of Trial Leaders (Forbes) (Bloomberg) (Forbes) (The Street)
  • The FDA Is Forcing Orexigen To Do A Second Safety Study Because Of Contrave Disclosures (Forbes) (Forbes) (BioCentury) (SCRIP-$)
  • Actelion says NDA for selexipag accepted by the US FDA (Reuters) (PharmaTimes)
  • FDA Accepts Bayer's Biologics License Application for Investigational Treatment Option in Hemophilia A (Press)

US: Pharmaceuticals and Biotechnology: General

  • Regulations not the only barrier to biosimilars in the US say analysts (Biopharma Reporter)
  • McDonald's USA to phase out human antibiotics from chicken supply (Reuters)
  • Execution of Georgia Woman Postponed; Problem With Drug (AP)
  • Patients Paying More for Specialty Drugs as Costs Continue to Rise (Pew)

US: Medical Devices

  • FDA: Manufacturer never had permission to sell device connected to superbug deaths (CNN)
  • How one Mobile App Maker got Clearance from FDA (QZ)
  • FDA Seeks Right Touch For Next-Gen Sequencing With Standards Groups (Pink Sheet-$)
  • Genetic Testing and FDA Regulation: Overregulation Threatens the Emergence of Genomic Medicine (JAMA-$)
  • How will precision medicine handle privacy concerns moving forward? (MedCityNews)
  • FDA clears 1 Hospira plant, flags another (Mass Device)
  • FDA Panel Hands Merz Support For Expanded Radiesse Filler Labeling (Gray Sheet-$)
  • Cost of a Recall of a Single-Center Experience Managing the Riata Defibrillator Lead (AJC-$)
  • FDA plans advisory committee hearing on duodenoscopes (Fierce)
  • After Five Years, Compliance-First Approach is Still Obstacle to Improving Product Quality (MasterControl)
  • Barco’s Nio 5MP LED Grayscale Display FDA Cleared for Radiology, Mammography (MedGadget)
  • Your Yearly Reminder That Personal Lubricant is, in Fact, a Medical Device (VICE)

US: Dietary Supplements

  • FDA Years-Long Crusade Against Supplement Firm Raises Questions About Enforcement (NPI)

US: Assorted And Government

  • Researchers find safety disclaimers do not register with consumers (MM&M)
  • SEC Provides Insight Into The Foreign Corrupt Practices Act and Life Science Companies (Policy and Medicine)
  • Senators to U.S. Trade Rep: End Trade Deal Secrecy (Senate)
  • Want to Help FDA out With its Data Security Measures? (Indeed)
  • U.S. Funds Efforts to Freeze Human Organs for Long-Term Storage (SciAm)
  • CBO Scores New DEA Reform Bill (CBO)

Upcoming Meetings

Europe

  • Patients should have a say in their medication, claims NICE (PMLive) (PharmaTimes)
  • The EMA at 20: A decade of expansion, collaboration and new legislation (SCRIP RA-$)
  • France Unveils New Update to its GMP Guidelines (ANSM)
  • What does disclosure mean for the UK? We ask the ABPI (PharmaTimes)
  • Early access: Taking stock of the options (Eye for Pharma)
  • Scottish reforms proven to work says SMC (Pharmafile)

India

  • India Guidance Would Make Sponsors Responsible for All Deaths in Trials (FDAnews-$)
  • DTAB Forms Subcommittee To Explore Pharmacovigilance (24 Insight)

China

  • Chinese business newspaper alleges kickback scheme among distributors for Siemens products (Fierce)

Canada

  • Canada's New Manufacturing Warnings Page (Health Canada)
  • Psoriasis drug gets stamp of approval from Health Canada (GlobalNews)

Other International

  • WHA mechanism on falsified drugs gaining momentum? (Securing Industry)
  • Nigeria: NAFDAC declares billionaire fake drug suspect wanted, arrests printer, others (Guardian) (Sun News)

General Regulatory And Interesting Articles

  • “New Drug” Designations for New Therapeutic Entities: New Active Substance, New Chemical Entity, New Biological Entity, New Molecular Entity (Medical Chemistry-$)
  • OTC medications and supplements are most common causes of drug-induced liver failure (Press)
  • Spider venom may hold chemical keys to new painkillers (Reuters)
  • A paralyzed woman flew an F-35 fighter jet in a simulator — using only her mind (WaPo)
  • Paracetamol use linked with cardiovascular risk and other adverse events (PharmJournal)
  • Quality control for adult stem cell treatment (MNT)

Regulatory Reconnaissance #506 – 4 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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