Regulatory Focus™ > News Articles > Regulatory Recon: Court Backs FDA Stance on Antibiotics Regulation (25 July 2014)

Regulatory Recon: Court Backs FDA Stance on Antibiotics Regulation (25 July 2014)

Posted 25 July 2014 | By Alexander Gaffney, RAC 

Regulatory Recon: Court Backs FDA Stance on Antibiotics Regulation (25 July 2014)

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

Regulatory Recon officially turns one year old today with the publication of our 365th edition. Here's to the next 365…

In Focus: US

  • Court Rules FDA Doesn’t Have to Ban Antibiotics Given to Food-Producing Livestock (Pharmalot) (NRDC) (Case) (Law 360-$) (Reuters)
  • Major Pending Recall for all lots Manufactured by Franck's, Lack of Sterility Cited (FDA)
  • Purdue’s Abuse-Deterrent Targiniq Is Different – Not Stronger – Than OxyContin (Pink Sheet-$) (Fierce) (MedPage Today)
  • A reminder of the promise and limitations of abuse-deterrent properties (FDA)
  • GSK's Flonase Gets FDA Approval to go OTC (Press)
  • FDA’s Expedited PMA Pathway Proposal: To Expand Or Contain? (Gray Sheet-$)

In Focus: International

  • CHMP Recommends Approval of Five New Drugs (EMA)
  • European Medicines Agency launches public consultation on rules of procedures for public hearings (EMA)
  • Is Europe putting cancer research at risk? (Press)

US: Pharmaceuticals and Biotechnology

  • Court Rules FDA Doesn’t Have to Ban Antibiotics Given to Food-Producing Livestock (Pharmalot) (NRDC) (Case) (Law 360-$) (Reuters)
  • Major Pending Recall for all lots Manufactured by Franck's, Lack of Sterility Cited (FDA)
  • Purdue’s Abuse-Deterrent Targiniq Is Different – Not Stronger – Than OxyContin (Pink Sheet-$) (Fierce) (MedPage Today)
  • A reminder of the promise and limitations of abuse-deterrent properties (FDA)
  • GSK's Flonase Gets FDA Approval to go OTC (Press)
  • Ethical considerations in design of a study to evaluate a FDA-approved indication: Antivenom versus placebo for copperhead envenomation (PubMed)
  • Is your drug name ok? Run a role-play, says FDA (In-Pharma)
  • US Biosimilars Pathway – A Step Closer to Reality (The Next Element)
  • Findings from a Mini-Sentinel Medical Product Assessment: Influenza Vaccines and Risk of Febrile Seizures (Brookings)
  • FDA Gives Equivalent Rating To Perrigo's Testosterone Gel (Law 360-$)
  • To make personalized medicine reality, Path2Cures speakers call for open data sharing (MedCity News)
  • Testing the Limits of Prescription Drug Preemption (D&D Law)
  • CBO Scores the Sunscreen Innovation Act (CBO)
  • Calif. Pharmacists Largely Oppose Translated Rx Drug Labels (CA Healthline)
  • Legislator Urges Rapid Approval of MenB Vaccine (Star Tribune)
  • Texas medical board charges controversial cancer doctor Burzinski (USA Today)

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

  • Bayer says Nexavar fails in breast cancer study (Reuters) (Pharma Letter-$) (Press)
  • Incyte misses goals in late-stage study of bone marrow disorder drug (MedCity News) (SCRIP-$)
  • Keryx drug improves phosphorus, iron in kidney patients: trial (Reuters) (Press)
  • Aduro nabs FDA 'breakthrough' nod for pancreatic cancer vaccine combo (Fierce)
  • FDA grants orphan drug status to experimental treatment for ‘stone man syndrome’ (MedCityNews)

US: Pharmaceuticals and Biotechnology: General

  • IRS Issues New Branded Prescription Drug Fee Regulations (IRS)
  • Ben Venue Laboratories, on the verge of closing months ago, getting a new owner (Cleveland Plain Dealer)
  • Diet Drug Maker's Last-Ditch Suit Against FTC Dismissed (Law 360-$)

US: Medical Devices

  • FDA’s Expedited PMA Pathway Proposal: To Expand Or Contain? (Gray Sheet-$)
  • Hypertension Experts Push For New Trial Of Renal Denervation To Show Efficacy (Gray Sheet-$)
  • FDA Classifies Implantable Transprostatic Tissue Retractor Systems as Class II Devices (FDA)
  • FDA Reclassifies Implanted Blood Access Devices as Class II (FDA)
  • Guided Therapeutics Files PMA Amendment with FDA for LuViva Advanced Cervical Scan (Press)
  • FDA Teams Up for Novel Campaign on Risks of Decorative Contact Lenses (FDA)

US: Dietary Supplements

  • District Court Enters Permanent Injunction Against New York Dietary Supplement Maker to Prevent Distribution of Adulterated Supplements (DOJ)

US: Assorted And Government

  • FDA Announces New Veterinary Information Sharing System for Federal and State Regulators (FDA)
  • FDA Enforcement Report (FDA)
  • Scalise Introduces Bill to Cap Regulatory Spending (Press)
  • Lou Gehrig's Disease is Rare, First US Count Finds (AP) (CDC)

Europe

  • CHMP Recommends Approval of Five New Drugs (EMA)
  • European Medicines Agency launches public consultation on rules of procedures for public hearings (EMA)
  • European Medicines Agency recommends approval of two new treatment options for rare cancers (EMA)
  • Novo wins EU recommendation for two-in-one diabetes drug (Reuters)
  • European CHMP Adopts Positive Opinion for Gilead’s Zydelig (idelalisib) for the Treatment of Chronic Lymphocytic Leukemia and Follicular Lymphoma (Press)
  • Allergan Announces OZURDEX (dexamethasone 700 mcg intravitreal implant in applicator) Receives European Positive Opinion for the Treatment of Diabetic Macular Edema (Press)
  • Is Europe putting cancer research at risk? (Press)
  • Italy to look at drug pricing during EU presidency (In-Pharma)
  • Medical Device Vigilance Reporting in Europe (Emergo Group)
  • NICE to OK single-shot radiotherapy for breast cancer (Pharma Times) (PharmaPhorum)
  • NICE gives final guidance on four products (SCRIP-$)
  • EMA uses regulatory tools to facilitate patient access to innovative Hepatitis medicines (EMA)
  • Boston Scientific lands another E.U. win, this time for Agent balloon (Mass Device)
  • UK Gov should seek licenses for off-patent drugs in new indications says MP (In-Pharma)
  • MHRA gives blessing to questioned emergency contraception (OnMedica)
  • Hundreds die each year in NHS due to faulty machines: report (Telegraph)

India

  • Lundbeck to seek legal recourse after health ministry bans Deanxit again (India Times)

Clinical Trials

  • eSource Data in Clinical Investigations: FDA Clarifies Guidance on Regulatory Considerations (Bioclinica)
  • Management of Patient Adherence in Clinical Trials Using Electronic Monitoring (EyeforPharma)
  • Clinical trials insight: oncology (PharmaPhorum)

General Regulatory And Interesting Articles

Regulatory Reconnaissance #365 – 25 July 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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