Regulatory Focus™ > News Articles > Regulatory Reconnaissance: FDA Approves More Versions of Generic Plan B One Step (28 February 2014)

Regulatory Reconnaissance: FDA Approves More Versions of Generic Plan B One Step (28 February 2014)

Posted 28 February 2014 | By Alexander Gaffney, RAC 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Read anything we might be interested in sharing? Let us know: news@raps.org.

Do you work in regulatory affairs? Take RAPS' Scope of Practice & Compensation Survey of the Regulatory Profession, a survey of professionals around the world who are involved with the regulatory process for healthcare products. It's the largest, most comprehensive study of the regulatory profession, and helps regulatory professionals benchmark their salary and compensation packages. All survey participants receive a free adanced copy of the report. (More)

In Focus: US

  • FDA Approves OTC Versions of Generic Plan B One Step for all Ages (Boston Globe) (FDA Law Blog) (Tan Sheet-$)
  • Amarin Sues FDA After the Agency Denies 5-Year NCE Exclusivity for VASCEPA (FDA Law Blog)
  • Government Says Supreme Court Should Not Take Up False Claims Act Case Alleging Off-Label Promotion (FDA Law Blog) (Law 360-$)
  • Generic-Drug Failures Spur Concern as FDA Steps Up Action (Bloomberg)
  • Former FDA Deputy Floats User Fee Solution To Drug Labeling Uproar (IHP-$)
  • Rep David Camp proposes repeal of Orphan drug tax credit (BioCentury)
  • FDA Data: Supplement cGMP Compliance Rates Show Modest Improvement (NPI)
  • Is the Government Entitled to Deference in FDA Criminal Cases? (FDA Law Blog)

In Focus: International

  • EMA Releases New Guideline on good pharmacovigilance practices (GVP) (EMA) (EMA)
  • CHMP disregards PRAC call to suspend Servier's Protelos in EU (SCRIP-$)
  • NICE says children with cancer should be allowed to take part in clinical trials (RPS)
  • NICE On Alimta, Pixuvri Ups Concerns It Prefers Cost Over Clinical Efficacy (Pink Sheet-$)
  • NICE rejects Alimta (Pharmafile) (Pharma Times) (PMLive) (Pink Sheet-$)

US: Pharmaceuticals/Biotechnology

  • FDA Approves OTC Versions of Generic Plan B One Step for all Ages (Boston Globe) (FDA Law Blog) (Tan Sheet-$)
  • Amarin Sues FDA After the Agency Denies 5-Year NCE Exclusivity for VASCEPA (FDA Law Blog)
  • Government Says Supreme Court Should Not Take Up False Claims Act Case Alleging Off-Label Promotion (FDA Law Blog) (Law 360-$)
  • Generic-Drug Failures Spur Concern as FDA Steps Up Action (Bloomberg)
  • Drug Firms Argue Against $1.2B Arkansas Judgment (AP) (Fierce)
  • Former FDA Deputy Floats User Fee Solution To Drug Labeling Uproar (IHP-$)
  • FDA: Rare Diseases in Children Pose Unique Challenges (FDA)
  • FDA Maps out Instances of Kidney Stones in Patients Taking Anti-Diabetic Medications (Mini-Sentinel)
  • Risk and Reward: Pharmacy Compounding of Clinical Materials (Gold Sheet-$)
  • 43 FY 2013 Drug GMP Warning Letters Hit Data Integrity, Training and More (Gold Sheet-$)
  • Jubilant Life resolves FDA-raised issues for Montreal facility (Press)
  • Purchaser Survey Supports FDA's Claim That Drug Shortages Decreasing (Pink Sheet-$)
  • Opinion: FDA's plan to ease drug shortages needs work (Examiner)
  • Cipla's HIV drug gets PEPFAR nod from FDA  (BioSpectrum)

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

  • Baxter's Advate helps prevent bleeding in one-year study of hemophiliacs (SCRIP-$)
  • Pacira Nerve Block Trial Hits Phase 3 Endpoint (Press)

US: Pharmaceuticals and Biotechnology: General

  • Rep David Camp proposes repeal of Orphan drug tax credit (BioCentury)
  • The Calculus of Cures (NEJM)
  • Most Rogue Sites Operate from Abroad, and Many Sell Counterfeit Drugs (GAO)
  • Chronically ill facing high drugs costs under U.S. health law (Reuters)
  • New US House bill would require drug testing for pharma employees (In-Pharma)
  • Hospitals coping better as drug shortages persist (AP) (Bloomberg)

US: Medical Devices

  • FDA eyes March for Staar ocular implant review (Fierce)
  • Still in the renal denervation space? Startups, consider adaptive trial design, CRO says (MedCity News)

US: Dietary Supplements

  • FDA Data: Supplement cGMP Compliance Rates Show Modest Improvement (NPI)
  • Should FDA Relax its Ban on Food and Supplement Health Claims? (Forbes)

US: Assorted And Government

  • Is the Government Entitled to Deference in FDA Criminal Cases? (FDA Law Blog)
  • On Regulatory Compliance and Social Media (MM&M)
  • FDA initiatives incorporate patient input and benefit-risk framework into real-life review process (SmartBrief)
  • Pelosi Officially Backs Eshoo To Succeed Waxman As Top E&C Democrat (IHP-$)
  • House votes to overhaul federal reg process (The Hill)
  • Boston Children's, Merck mine social media to study sleep health (MobiHealthNews)

Upcoming Meetings And Events

  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

  • EMA: Guideline on good pharmacovigilance practices (GVP): 4 Module XVI- Risk minimisation measures: selection of tools and effectiveness indicators (EMA) (EMA)
  • CHMP disregards PRAC call to suspend Servier's Protelos in EU (SCRIP-$)
  • NICE says children with cancer should be allowed to take part in clinical trials (RPS)
  • NICE On Alimta, Pixuvri Ups Concerns It Prefers Cost Over Clinical Efficacy (Pink Sheet-$)
  • NICE rejects Alimta (Pharmafile) (Pharma Times) (PMLive) (Pink Sheet-$)
  • CHMP Issues Positive Opinion for Tablet Formulation of Merck's Noxafil (posaconazole) (Press)
  • AZ to resume marketing Forxiga in Germany (BioCentury)
  • EMA to review MDCO's oritavancin (BioCentury)
  • Europe slow to adopt anti-abuse formulations and tech, says expert (In-Pharma)
  • EUnetHTA Releases Second Pilot Rapid Assessment of Invokana (EUnetHTA)

India

  • India Creates New Hazard Category For Potent Antibiotics, Painkillers (PharmAsia-$)
  • Opinion: India's Drug Laws Are Obsolete (S4S)

Japan & China

  • China Regulatory Update: CFDA Releases New Drug Registration Draft, GSP Inspection Guidelines (PharmAsia-$)
  • Japan's First Committee On Drugs Approves 11 Drugs Including Two SGLT2 Inhibitors (PharmAsia-$)
  • Two more SGLT2 inhibitors recommended in Japan (SCRIP-$)
  • Japan Diovan Probe Expanded To Cozy Drug-Study Relationships (PharmAsia-$)

Other International

  • Australia Investigating Effectiveness of Levonorgestrel in Women Over 70 kg (TGA)
  • New Zealand guidelines for biosimilars (GABI)

General Regulatory And Interesting Articles

  • Regulation of medicines and medical devices: contrasts and similarities (ClinMed)
  • Cost-effectiveness analyses of personalized medicine: How much uncertainty is acceptable? (CEA)
  • Teenagers Treated for Headache Were Prescribed Opioids Almost Half of the Time, According to Study in Journal of Adolescent Health (Press)
  • Infographic: What Is A Crossover Study? (Lilly COI)
  • Middle income countries face obstacles in access to drugs despite making them, study finds (In-Pharma)
  • GSK's Witty loses bonus over China scandal (Pharmafile)
  • Artificial Muscles to Power Prostheses, Robots, Medical Devices (MedGadget)

Regulatory Reconnaissance #266 - 28 February 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.

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.


Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe