Regulatory Focus™ > News Articles > Regulatory Reconnaissance: FDA Unveils New Pharma Compounding Policies (2 July 2014)

Regulatory Reconnaissance: FDA Unveils New Pharma Compounding Policies (2 July 2014)

Posted 02 July 2014 | By Alexander Gaffney, RAC 

Regulatory Reconnaissance: FDA Unveils New Pharma Compounding Policies (2 July 2014)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Your editor is on “vacation” this week. Regulatory Reconnaissance will continue as scheduled, but all other news is on hold until 7 July 2014.

 

In Focus: US

  • FDA outlines expectations for human drug compounders ( FDA) ( Law 360-$) ( Pink Sheet-$) ( SCRIP-$) ( Outsourcing Pharma) ( Guidance) ( Guidance) ( FR) ( FR) ( FR)
  • FDA seeks permanent injunction against California pharmaceutical company ( FDA) ( DOJ)
  • New Drug And Device Approval: What Is Sufficient Evidence? ( Health Affairs)
  • Top 10 Reasons for FDA Warning Letters to Medical Device Firms ( MDS)
  • FDA CDRH Workshop on Future Guidance Documents ( Policy and Medicine)
  • St. Jude Medical Resolves FDA Warning Letter for Sylmar Facility ( Press)
  • Regulatory science and globalization top FDA's four-year plan ( BioCentury)

In Focus: International

  • A Breakthrough Therapies Pathway In Europe? Not Likely, Regulators Say ( RPM Report-$)
  • Success Of Bristol’s Daklinza In Europe May Be Tied To Fate Of Sovaldi ( Pink Sheet-$)
  • First product through EU's advanced therapies regulation gets approval renewed ( SCRIP-$)
  • ‘Huge Demand for Compliance, Regulatory’ Staff at Indian Pharma Companies ( India Times)
  • Can we trust any Indian generic heart medicines? ( The Hill)
  • Indian Pharma Industry Worried About Chinese APIs ( India Times)
  • Health Canada to follow IMDRF unique device identification framework ( Mass Device)

US: Pharmaceuticals and Biotechnology

  • FDA outlines expectations for human drug compounders ( FDA) ( Law 360-$) ( Pink Sheet-$) ( SCRIP-$) ( Outsourcing Pharma) ( Guidance) ( Guidance) ( FR) ( FR) ( FR)
  • FDA seeks permanent injunction against California pharmaceutical company ( FDA) ( DOJ)
  • Is the Issuance of a Pediatric Written Request a Condition Precedent to FDA Awarding Pediatric Exclusivity? A New Citizen Petition Pushes FDA to Answer the Question ( FDA Law Blog)
  • New Drug And Device Approval: What Is Sufficient Evidence? ( Health Affairs)
  • The Lab for These FDA Scientists Is a Computer Screen ( FDA)
  • Office of Prescription Drug Promotion Enforcement Overview ( Reuters)
  • Walgreen, CalPERS Lobby FDA To Drop Biosimilars Naming ( Law 360-$)
  • Is Regulatory Transformation for Alzheimer’s Therapies Needed? ( BIO)
  • Antibiotic Trial Network Could Emerge From FDA/NIH Workshop ( Pink Sheet-$)
  • DEA Places Tramadol Into Schedule IV ( DEA)
  • Bayer Launches FDA-Approved Soft Chew for Canine Osteoarthritis Pain Management ( Press)

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

  • POZEN Resubmits PA8140/PA32540 NDA ( Press)
  • Salix reports Phase III IBS-D data ( BioCentury) ( SCRIP-$)

US: Pharmaceuticals and Biotechnology: General

  • Express Scripts Ends Coverage for 1,000 Compound Drug Ingredients ( Pharmalot)
  • State Of The Painkiller Nation: Wide Variation In Prescription Rates ( NPR)
  • Prescription Overdose Deaths in Florida Plunge After Tougher Measures, Report Says ( NYTimes)
  • NABP enters a 'registry agreement' with ICANN for the .Pharmacy web-address suffix ( Pharma Commerce)

US: Medical Devices

  • Top 10 Reasons for FDA Warning Letters to Medical Device Firms ( MDS)
  • 6 More Inspectional Insights From FDA Experts ( Silver Sheet-$)
  • FDA CDRH Workshop on Future Guidance Documents ( Policy and Medicine)
  • St. Jude Medical Resolves FDA Warning Letter for Sylmar Facility ( Press)
  • Study Offers Reassurance About Newer Drug-Eluting Stents ( Forbes)
  • Thermedx gets 510K clearance for fluid warming system ( MedCity News)
  • Inova Labs Receives FDA Clearance for Activox DUO2 - The First Integrated Stationary and Portable Oxygen Concentrator System ( Press)
  • AEM EndoShield Burn Protection System for Laparoscopic Instruments FDA Cleared ( MedGadget)
  • Dallen Medical Receives FDA Clearance for Disposable Compressyn Staple Delivery System for Small Bone Fixation ( Press)
  • MQSA National Statistics ( FDA)
  • Unapproved device buys time for new pair of lungs ( AP)

US: Dietary Supplements

  • U.S. Files Complaint and Consent Decree Against Mira Health and Senior Officers ( DOJ)

US: Assorted And Government

  • New FDA Warning Letters Posted ( FDA)
  • Regulatory science and globalization top FDA's four-year plan ( BioCentury)
  • FDA's Patient Outreach: Finding Ties that Bind ( PharmExec)
  • NIH names new clinical sites in Undiagnosed Diseases Network ( NIH) ( SCRIP-$)
  • Patent Office Might Get Rx Favor; J&J Lawyer Eyed For Top Post ( Pink Sheet-$) ( Vox)
  • 16 Health Outcomes of Interest for Surveillance Preparedness ( Mini-Sentinel)
  • L’Oreal agrees to settle FTC charges for misleading ads ( Cosmetics Design)

Europe

  • A Breakthrough Therapies Pathway In Europe? Not Likely, Regulators Say ( RPM Report-$)
  • Success Of Bristol’s Daklinza In Europe May Be Tied To Fate Of Sovaldi ( Pink Sheet-$)
  • First product through EU's advanced therapies regulation gets approval renewed ( SCRIP-$)
  • The Falsified Medicines Directive – What Does It Really Mean? ( LifeSci Leader)
  • Boehringer Ingelheim submits applications in Europe for tiotropium + olodaterol Respimat fixed-dose combination in COPD ( Press)
  • David Cameron calls for global response to superbugs ( Guardian) ( Guardian) ( Pharma Times) ( UK) ( Reuters) ( Bloomberg)
  • EMA provides guidance on CKD clinical trials ( BioCentury)
  • France to back Roche cancer drug as cheaper eye treatment ( Reuters)

India

  • ‘Huge Demand for Compliance, Regulatory’ Staff at Indian Pharma Companies ( India Times)
  • Can we trust any Indian generic heart medicines? ( The Hill)
  • CDSCO issues guidelines on pharmacovigilance requirements for biological products ( PharmaBiz)
  • Indian Pharma Industry Worried About Chinese APIs ( India Times)

Japan & China

  • Seven Weeks On, Still No China Generic Of Pfizer's Viagra Drug Sold ( PharmAsia-$)

Other International

  • Health Canada to follow IMDRF unique device identification framework ( Mass Device)
  • South Africa regulator gives MSF access to cheaper TB drug linezolid ( Pharma Letter-$)

Clinical Trials

  • Discrepancies in reporting analyses of clinical trials are “common” ( AllTrials)

General Regulatory And Interesting Articles

  • Best Practices For Designing Cell-Based cGMP Facilities ( LifeSci Leader)
  • Looking to Automated Compounding Systems to Remove Human Error ( Medical Design)
  • Stem Cell Transplant Stops Sickle Cell in Potential Cure ( Bloomberg)
  • Using Evidence to Combat Overdiagnosis and Overtreatment: Evaluating Treatments, Tests, and Disease Definitions in the Time of Too Much ( PLoS)
  • Can a Device Help Dogs Detect Cancer in Humans? ( MNT)

Regulatory Reconnaissance #349 – 2 July 2014

RegulatoryReconnaissance is our daily intelligence briefing for the regulatory affairsspace, bringing you the top regulatory news stories from around the globe. Eachweekday morning, we aim to bring you the latest highlights of new approvals,meetings, legal and political developments, regulations and guidance, and thelatest trends with the potential to impact regulatory affairs professionals andthe industry in which they work.

Did we miss a story?Send us a tweet at @RAPSorg and we'll check it out for inclusion in ournext edition of Regulatory Reconnaissance. Want this in your inbox eachmorning? Sign up for RF Today, our morning intelligence newsletter here.

Need to contact theeditor of Regulatory Reconnaissance? Find him on Twitter at @AlecGaffney or send him an email at news@raps.org.


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