Regulatory Focus™ > News Articles > Regulatory Reconnaissance (2 August 2013)

Regulatory Reconnaissance (2 August 2013)

Posted 02 August 2013 | By Alexander Gaffney, RAC 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Your editor is taking every Friday off in August for vacation, but is making sure to keep you up-to-date with Regulatory Reconnaissance.

In Focus: "Would Have Written About These" Highlights

  • BIO Whitepaper Calls for 12 Years of Biologics Exclusivity in Trade Deal (BIO) (BIO)
  • BIO, PhRMA, AdvaMed, GPhA, MITA Join Together to Support Senate Bill to Exempt FDA User Fees from Sequestration (PR)
  • EMA begins internal reorganization (BioCentury) (EMA)
  • FDA Wants to Data Mine Literature Reports for Adverse Event Signals (FDA)
  • IOM Report: International Regulatory Harmonization Amid Globalization of Drug Development (IOM)
  • EMA Recommends Approval of 44 Medicines for Human Use in First Half 2013 (EMA) (SCRIP)
  • Guideline On Pharmaceutical Development Of Medicines For Paediatric Use (EMA)

In Focus: US

  • BIO, PhRMA split on special use pathway (BioCentury)
  • Regulatory Woes Contribute to Second-Quarter Loss for Teva (Philadelphia Enquirer) (DD&D)
  • OMB Signs off on FDA's Proposed Study on DTC Prescription Drug Advertising With Compositive Scores (OMB)
  • Hospira Heads in Right Direction but 483s and Warnings Still Coming (In-Pharma Technologist)
  • PDUFA, Biosimilar Application Fees To Rise 10.7%; FDA's Workload Adjuster Needs Work (Pink Sheet)
  • FDA Warns Acetaminophen Can Cause Rare Skin Diseases (FDA) (FDA) (FDA) (WSJ) (Reuters) (NPR) (MedPage Today)
  • FDA Wants to Data Mine Literature Reports for Adverse Event Signals (FDA)
  • Hacking: Another year, another insulin pump maker outed on stage (Mass Device)
  • FDA Announces Advisory Committee Meeting to Discuss Ocular Therapeutix's ReSure Sealant (FDA)
  • Lawmakers Press Administration For Answers On Sequestered FDA Fees (IHP)

In Focus: International

  • EMA Recommends Approval of 44 Medicines for Human Use in First Half 2013 (EMA) (SCRIP)
  • EC sets up expert group on rare diseases (PMLive)
  • Guideline On Pharmaceutical Development Of Medicines For Paediatric Use (EMA)
  • European Medicines Agency introduces digital signatures for selected procedures (EMA)
  • India board revokes GSK patent on breast cancer drug Tykerb (Reuters) (Pharma Times)
  • Sanofi and Glaxo's emerging market woes highlight need for greater disclosure (EP Vantage)

Comments? Suggestions? Email me at news@raps.org.

US

Pharmaceuticals/Biotechnology
  • BIO Whitepaper Calls for 12 Years of Biologics Exclusivity in Trade Deal (BIO) (BIO)
  • BIO, PhRMA split on special use pathway (BioCentury)
  • Regulatory Woes Contribute to Second-Quarter Loss for Teva (Philadelphia Enquirer) (DD&D)
  • OMB Signs off on FDA's Proposed Study on DTC Prescription Drug Advertising With Compositive Scores (OMB)
  • Hospira Heads in Right Direction but 483s and Warnings Still Coming (In-Pharma Technologist)
  • PDUFA, Biosimilar Application Fees To Rise 10.7%; FDA's Workload Adjuster Needs Work (Pink Sheet)
  • FDA Announces Fiscal Year 2014 User Fee Rates; They're Movin' On Up! (FDA Law Blog)
  • Generic User Fees Jump To Cover Inflation Increase, Backlog Fee Elimination (Pink Sheet)
  • Pharmaceutical Compounder Launches Nationwide Recall due to Lack of Sterility Assurance (FDA) (FDA)
  • Tolvaptan OK Would Require Unusual Tolerance Of Drug-Induced Liver Injury (Pink Sheet) (BioCentury)
  • Industry Weighs in on GFI on Glass Syringes (FDA Docket)
  • FDA Warns Acetaminophen Can Cause Rare Skin Diseases (FDA) (FDA) (FDA) (WSJ) (Reuters) (NPR) (MedPage Today)
  • FDA Wants to Data Mine Literature Reports for Adverse Event Signals (FDA)
  • FDA Announces Advisory Committee Meeting for GSK's Anoro Ellipta (FDA) (BioCentury)
  • FDA Announces Withdrawal of NDA for Pfizer's Bextra (10 mg/20 mg) (FDA)
  • Halozyme takes a second hit after safety fears scuttle PhII combo study (Fierce)
  • Strides Arcolab gets USFDA nod for anti-AIDS combination drug (India Times)
  • FDA expands age indication for Menveo, quadrivalent meningococcal vaccine (Pharma Letter) (Novartis)
  • Draft Guidance for Industry: Bioequivalence Recommendations for Mesalamine Rectal Suppositories (FDA)
  • BioDelivery submits NDA for opioid dependence product (BioCentury)
  • Omeros seeks approval for OMS302 (BioCentury) (Xconomy)
  • FDA Applies for Extension on GFI: Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components for Transfusion (FDA)
  • Actelion to buy Ceptaris, as long as FDA OKs Valchlor (SCRIP)
  • Pacira Pharma pain drug fails late-stage trial (Reuters)
Pharmaceuticals: General
  • Morning-after pill now available on store shelves (ABC)
  • First aid for snakebite could come in a nasal spray, researcher says  (NBC)
  • Drugmakers Extend Discounts And Price Freezes To State AIDS Programs (Pharmalot)
Medical Devices
  • Hacking: Another year, another insulin pump maker outed on stage (Mass Device)
  • FDA Announces Advisory Committee Meeting to Discuss Ocular Therapeutix's ReSure Sealant (FDA)
  • PREVOR v. FDA: Round II in Court (FDA Law Blog)
  • Apira Science's iGrow In-Home, Hands-Free Hair Growth System Earns FDA Clearance (Apira) (MedGadget)
  • NEC Display Solutions Receives FDA 510(k) Clearance on MD211G5 Medical Diagnostic Monitor (NEC)
  • FDA clears Teratech's Windows tablet-based ultrasound system (MedGadget)
  • FDA Clears Hologic's Single Energy Femur Exam to Visualize Features Associated with Developing Atypical Femur Fractures on a DXA Platform (Hologic)
  • FDA expands clearance for Teleflex's Arrow balloon dilatation catheters (Mass Device)
  • OMB Approves Medical Device User Fee Cover Sheet, Form FDA 3601 (FDA)
Assorted And Government
  • IOM Report: International Regulatory Harmonization Amid Globalization of Drug Development (IOM)
  • BIO, PhRMA, AdvaMed, GPhA, MITA Join Together to Support Senate Bill to Exempt FDA User Fees from Sequestration (PR)
  • Lawmakers Press Administration For Answers On Sequestered FDA Fees (IHP)
  • Senate joins effort to unlock FDA user fees (BioCentury)
  • 6 Questions For A Veteran FDA Investigator (FDAzilla)
  • FDA Again Cited by Congress for Helping to Promote Healthcare Law (Senate)
  • GAO Report Lauds FDA for Collaborating With International Regulators (GAO)
  • Purity First Health Products, Inc. Issues Nationwide Recall of Specific Lots of Healthy Life Chemistry B-50, Multi-Mineral and Vitamin C Products: Due to a Potential Health Risk (FDA)
  • Medical device tax repeal bill has 259 co-sponsors with more on the way (Mass Device)
  • House sets up REINS Act, carbon tax vote for Friday (The Hill)
  • Advocates bemoan 'regulatory paralysis' (The Hill)
Upcoming Meetings And Events
  • 25-26 July 2013: Meeting on Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (FDA)
  • 29 July 2013: Workshop on Clinical Development Programs for Opioid Conversion (FDA)
  • 30-31 July 2013: Workshop on Battery-Powered Medical Devices (FDA)
  • 31 July 2013: Nonprescription Drugs Advisory Committee Meeting  (FDA)
  • 2 August 2013: Blood Products Advisory Committee Meeting (FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

  • EMA begins internal reorganization (BioCentury) (EMA)
  • EMA Recommends Approval of 44 Medicines for Human Use in First Half 2013 (EMA) (SCRIP)
  • EC sets up expert group on rare diseases (PMLive)
  • Guideline On Pharmaceutical Development Of Medicines For Paediatric Use (EMA)
  • EC approves Aegerion's lomitapide for hoFH (BioCentury) (BioFlash)
  • Regulatory information - European Medicines Agency introduces digital signatures for selected procedures (EMA)
  • Reflection paper on management of clinical risks deriving from insertional mutagenesis (EMA)
  • Concept paper on development of product-specific guidance on demonstration of bioequivalence released for a two-month public consultation (EMA) (Paper)
  • Guideline on medicines for the treatment of amyotrophic lateral sclerosis released for a six-month public consultation (EMA) (Guideline)
  • Explanatory note on the withdrawal of the note for guidance on harmonisation of requirements for influenza Vaccines (EMA)
  • Top French court backs stem-cell research (Reuters)
  • E-labeling in the EU - some practical experience and: Save the apps market! (MedDevices Legal)
  • Reflection paper on management of clinical risks deriving from insertional mutagenesis (EMA)
  • German Trobalt reassessment encounters delays (BioCentury)

Asia

  • Sanofi and Glaxo's emerging market woes highlight need for greater disclosure (EP Vantage)
  • J&J, Mulund FDA Told to Resolve Dispute Involving Closure of Manufacturing Facility (Times of India)
  • India board revokes GSK patent on breast cancer drug Tykerb (Reuters) (Pharma Times)
  • Prelim nod for SkyePharma/Kyorin's Flutiform in Japan (SCRIP)
  • Russian Government May Exclude Foreign Manufacturers from Certain Medical Device Tenders (Medtech Insider)
  • China mulls fixed reimbursement by active ingredient (SCRIP)

General Regulatory And Interesting Articles

  • When Fleeing Zombies (Or Flu), Cooperation Saves Lives (NPR)
  • When prescribing antibiotics, doctors most often choose strongest types of drugs (EurekAlert)
  • Whooping cough booster not enough to stop outbreaks (Reuters)
  • Assessing the Value of Retrospective Studies: Real-World Data, Real-World Applications (PharmExec)

Regulatory Reconnaissance #123  - 2 August 2013

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.

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

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


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