Regulatory Focus™ > News Articles > Regulatory Recon: Software Issue May Mean Incorrect Data Used to Support Generic Drug Approvals (13

Regulatory Recon: Software Issue May Mean Incorrect Data Used to Support Generic Drug Approvals (13 October 2014)

Posted 13 October 2014 | By Alexander Gaffney, RAC

Regulatory Recon: Software Issue May Mean Incorrect Data Used to Support Generic Drug Approvals (13 October 2014)

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

In Focus: US

In Focus: International

  • Canadian Ebola Vaccine to Be Shipped to Geneva Next Week, WHO Said (Canadian Press)
  • Experts question ethics of placebo drug trials in case of Ebola (Reuters)
  • Surprise! More on unannounced audits, this time on software (MDL)
  • Bayer urges rebellion against NICE no for Sativex (SCRIP-$)
  • Reflection paper on the requirements for selection and justification of starting materials for the manufacture of chemical active substances (EMA)
  • New ICH Concept Papers Released (ICH) (ICH)

US: Pharmaceuticals and Biotechnology

  • Software issue casts doubt over data used to approve some drugs (Reuters)
  • Gilead wins FDA approval for its hep C combo pill, a blockbuster in the making (Fierce) (BioCentury) (PharmaTimes) (Pink Sheet-$) (The Street) (MedPage Today) (SCRIP-$) (Law 360-$)
  • FDA approves Akynzeo for nausea and vomiting associated with cancer chemotherapy (FDA) (BioCentury) (PharmaTimes) (MedPage Today) (Press)
  • FDA Approves Lumason Microsphere Echo Contrast (Medscape) (FDA)
  • FDA raps Sun Pharmaceuticals for delay in follow-up for recalled drugs from US market (India Times)
  • Can FDA Finally Put Its Zohydro Problem Behind It? (Pink Sheet-$)
  • Takeda wins temporary reprieve for controversial gout drug Colcrys (Fierce)
  • FDA Issues Final Guidance on Terminology for Veterinary Medicinal Products Adverse Event Reporting (FDA)
  • Teen activist files lawsuit challenging FDA ban on gay blood donors (LGBTnation)
  • Comparative Data On Inhibitor Side Effects Sought By Hemophilia Patients (Pink Sheet-$)
  • FDA, farmers still debate the use of antibiotics in animals (WaPo)
  • Observations on the GDUFA Regulatory Science Priorities (Two-Four Insight)
  • Key Points of OPDP's Bad Ad Program (FDA)
  • Will GS1’s EPCIS Be Used Widely For DSCSA Data Exchange? (RxTrace)
  • The Brighton Collaboration Viral Vector Vaccines Safety Working Group (V3SWG) (PubMed)
  • FDA’s Early Breast Cancer pCR Final Guidance Stresses One Trial (Pink Sheet-$)
  • Oregon Compounding Centers, Inc. Unexpired Sterile Products: Recall - Lack of Sterility Assurance (FDA)
  • Bristol-Myers, Otsuka ask judge to nix Abilify kickback suit (Fierce)

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

  • Pfizer Announces FDA Acceptance Of Palbociclib New Drug Application With Priority Review (Press)
  • Prosensa heads to the FDA with its once-failed DMD treatment (Fierce) (PharmaPhorum) (SCRIP-$)
  • Orexo Submits Application to FDA for Expanded Label of ZUBSOLV (Press)
  • BIT225 Trial Results Show Effective Cure of Hepatitis C (Press)
  • Novartis' secukinumab has 'consistent' activity in psoriasis (PMLive) (PharmaTimes)
  • Positive Ph III results for Ipsen’s Decapeptyl in prostate cancer patients (PharmaLetter-$) (Press)
  • Nuvilex Applies to FDA for Orphan Drug Designation for Its Cell-in-a-Box Treatment for Pancreatic Cancer (Press)

US: Pharmaceuticals and Biotechnology: General

  • ASCO’s Tool For Scoring Cancer Drug Value To Be Released In Early 2015 (Pink Sheet-$)
  • Opinion: Local Drug Disposal Tax Should Go Down The Drain (D&D Law)
  • Pharmaceutical Companies Share Data For Drug Design (Press)
  • Comment Period Open on Special 301 Report on India (USTR)

US: Medical Devices

  • First Drug-Coated Balloon Approved By FDA For Leg Blockages (Forbes) (Press) (Mass Device) (Gray Sheet-$) (FDA)
  • Draft Guidance on Flow Cytometric Devices (FDA) (Gray Sheet-$) (FR)
  • FDA Asks Glucose Monitor Hackers For Gap Analysis Report (Gray Sheet-$)
  • FDA panel recommends PMA process for CryoLife heart valve (Mass Device) (MedPage Today)
  • Smith & Nephew 'spray-on-skin' for leg ulcers flops in trial (Reuters) (RTT) (Fierce)
  • Risk of botched laser job runs high (Gannett)
  • FDASIA legislation? Don't be so hasty to Act on Draft Recommendations, Says Expert (mHealthNews)
  • FDA Approves VisionCare's Telescope Implant for Macular Degeneration in Patients 65 Years and Older (Press)
  • Nanosphere Gets FDA 510(k) Clearance For More Viral Targets In Stool Test (RTT)
  • C.R. Bard Settles Vaginal Mesh Suits For $21 Million (MedDeviceOnline)
  • SAM Junctional Tourniquet Accessory (Axilla) Strap - SAM Medical Products: Recall - Potential Clip Failure (FDA)
  • ClearFlow Announces Positive Clinical Trial Results for the Reduction of Hospital Complications after Heart Surgery (Press)

US: Dietary Supplements

  • FTC Sets “New Normal” For Study Data Reviews, Prioritizes Health Product Claims Enforcement (Tan Sheet-$)

Upcoming Meetings

Ebola Outbreak

  • Canadian Ebola Vaccine to Be Shipped to Geneva Next Week, WHO Said (Canadian Press)
  • Experts question ethics of placebo drug trials in case of Ebola (Reuters)
  • NIH's Collins: Budget Cuts May Have Prevented Development of an Ebola Vaccine (HuffPo)
  • Answering Your Questions About Ebola Treatments And Vaccines (NPR)
  • Calling All Innovators to Help Fight Ebola (Whitehouse)
  • Dallas Nurse Who Cared For Duncan Contracts Ebola: 'Inadvertent Breach Of Protocol" (Forbes)
  • How Ebola killed Thomas Duncan (AP)

Europe

  • Surprise! More on unannounced audits, this time on software (MDL)
  • Bayer urges rebellion against NICE no for Sativex (SCRIP-$)
  • Reflection paper on the requirements for selection and justification of starting materials for the manufacture of chemical active substances (EMA)
  • Germany says Novartis's Gilenya has no added benefit (SCRIP-$)
  • Janssen Seeks Approval of Psoriasis Drug (Press)
  • Understanding the NICEties of medical devices (Clinica-$)

India

  • After years of discussions, DoP yet to finalise policy on pricing of patented drugs (PharmaBiz)
  • SC agrees to hear petition challenging withdrawal of internal guidelines by NPPA (PharmaBiz)
  • Experts seek clarifications on notification on medical devices from govt (PharmaBiz)

Other International

  • New ICH Concept Paper: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management (Q12) (ICH)
  • New ICH Concept Paper: Revision of the M4E Guideline on Enhancing the Format and Structure of Benefit-Risk Information in ICH (M4E(R2)) (ICH)

Clinical Trials

  • Society of Clinical Research Associates-Food and Drug Administration: Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good Clinical Practice; Public Workshop (FDA)

General Regulatory And Interesting Articles

  • Slippery When Coated: Helping Medical Devices Prevent Blood Clots (NPR)
  • The Dwindling Stock of Antibiotics, and What to Do About It (AP)
  • Bill and Melinda Gates Foundation funds Pfenex vaccine R&D (BioPharma-Reporter)
  • Halal: accessing the untapped $30bn pharma market (In-Pharma)
  • Oxycodone may be riskier than other addictive opioids, research suggests (PharmJournal)

Regulatory Reconnaissance #419 – 13 October 2014

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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