Regulatory Focus™ > News Articles > Regulatory Recon: FDA Panel Wants Stronger Warnings for Widely-Prescribed Antibiotics (6 November 20

Regulatory Recon: FDA Panel Wants Stronger Warnings for Widely-Prescribed Antibiotics (6 November 2015)

Posted 06 November 2015 | By Michael Mezher 

Regulatory Recon: FDA Panel Wants Stronger Warnings for Widely-Prescribed Antibiotics (6 November 2015)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher, @Zachary Brennan and @RAPSorg on Twitter.

In Focus: US

  • FDA approves Gilead Sciences' HIV drug cocktail (Reuters) (FDA) (NYTimes) (Press)
  • Under siege, drug makers ready their counterpunch (STAT)
  • FDA Panel Seeks Tougher Antibiotic Labels (Pink Sheet-$) (WSJ-$)
  • FDA Spotlights Products “Fraudulently Marketed for Serious Diseases” (FDA Law Blog)
  • Federal Officials Warn States on Hepatitis C Drug Restrictions (WSJ-$) (CMS Blog)
  • From our perspective: The importance of the physical characteristics of generic drugs (FDA)

In Focus: International

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US: Pharmaceuticals and Biotechnology

  • Rethinking the Use of Methadone as a Preferred Treatment for Pain (Pew)
  • Further US-EU harmonisation increases emphasis on delamination (Manufacturing Chemist)
  • Report: Orphan drugs cost 13.8 times more per patient (MedCityNews)
  • Non-originator low molecular weight heparins: generics or biosimilars (GaBI)
  • FDA Has Reasons To Remove Oral Phenylephrine From Monograph – Petition (Tan Sheet-$)
  • AstraZeneca cancer drug may not be so fast getting to market (Reuters) (SCRIP-$)
  • Pfizer expands income eligibility to its free drug program (Modern Healthcare-$) (DSN) (Pfizer)

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

  • ArmaGen Receives Rare Pediatric Disease Designation from FDA for AGT-181 for the Potential Treatment of Hurler Syndrome (Mucopolysaccharidosis Type I) (Press)
  • Additional Phase 3 Data Supporting OPKO’s Rayaldee as a Treatment for Secondary Hyperparathyroidism in Chronic Kidney Disease to be Presented at Kidney Week 2015 (Press)
  • BioLineRx Announces Positive Clinical Results from First Part of Phase 2 Trial in r/r AML (Press)
  • Takeda to Present Data from Ixazomib’s Phase 3 Study in Relapsed/Refractory Multiple Myeloma at Upcoming American Society of Hematology Annual Meeting (Press)
  • Alzheon Announces Efficacy Outcomes from Two Prior Tramiprosate Phase 3 Studies (Press)
  • Alzheon Announces Initiation of Clinical Studies with ALZ-801 Bridging to Pivotal Phase 3 Study in Alzheimer’s Disease (Press)

US: Medical Devices

  • US FDA Tries To Get 'Smart' In Standardizing 510(k) Reviews (SCRIP-$)
  • EpiPen injuries are rare but may be serious for children (Reuters)
  • Duke study: Weight loss app caused no improvement over control group (MobiHealthNews)
  • Yale launches ResearchKit app to study and prevent pregnancy loss (MobiHealthNews)
  • FDA adds another artificial kidney to its Expedited Access Pathway program (FierceMedicalDevices) (UCSF)
  • INVOcell Intravaginal IVF Embryo Incubator FDA Approved (medGadget)
  • Google Science Fair Winner: Conn. Teen Invents New Ebola Test (CBS)
  • An easy test for sickle cell disease (MNT)
  • Theranos Searches for Lab Director to Oversee Laboratory (WSJ-$)
  • Guided Therapeutics pushes back FDA date for LuViva device (MassDevice) (Press)
  • Convergent Dental Announces FDA Clearance of Osseous Tissue Procedures for Solea at ADA 2015 (Press)
  • REALITY Study To Evaluate Use Of Directional Atherectomy And Drug-Coated Balloon In Patients With Peripheral Arterial Disease (MedDeviceOnline)
  • TherOx wins FDA IDE nod for Supersaturated Oxygen therapy (MassDevice)

US: Assorted and Government

  • Ethicon Stapler Suit Belongs Outside US, 6th Circ. Told (Law360-$)
  • Genentech Beats Off-Label Use Lawsuit for Avastin (Big Molecule Watch)
  • Three Medical Innovation Priorities Ready for Congressional Actiong (Bipartisan Policy Center)
  • PhRMA Pushing For Policies To Facilitate Outcomes-Based Pricing (Pink Sheet-$)
  • The Last Decade’s Culture Wars Drove Some States To Fund Stem Cell Research (Kaiser)
  • Chicago claims to release new details about deceptive opioid marketing (Pharmalot)

Upcoming Meetings and Events              


  • Portuguese DPA’s guidelines on personal data processing for clinical research purposes (CRA Law)
  • The Future EU IVD Regulation: Practical Tips And Why The Sector Needs To Start Work Now (Clinica-$)
  • NICE issues negative draft guidance on Unituxin (PharmaLetter-$)
  • Infections associated with heater cooler units used in cardiopulmonary bypass and ECMO (MHRA)
  • MHRA seize huge haul of potentially dangerous slimming pills (MHRA)
  • UK doctors embracing technology, but not for their patients, survey reveals (Pharmafile)
  • UK innovation drive will change licensing, reimbursement and trials (In-PharmaTechnologist)
  • Let doctors use off-patent drugs in new ways (The Guardian)
  • EFPIA Responds to the Opinion of the Expert Panel of the Commission on Access to Health Services in the EU (EFPIA)
  • Lessons learnt for public health from the Ebola outbreak in West Africa – how to improve preparedness and response in the EU for future outbreaks (European Commission) (Report)
  • Sierra Leone beds in against Ebola repeat with UK military’s 'hospital in a box' (The Guardian)


  • TGA presentation given at the ARCS regulatory affairs interest area meeting, 15 September 2015 (TGA)
  • Counterfeit medicines and medical devices (TGA)


  • PhRMA supports India’s efforts to enhance patient access to quality healthcare (Pharmabiz)
  • Prices of 98 drugs not fixed due to non availability of information (Economic Times)
  • Merck & Co to expand in India, favourable IPR ruling encourages co to invest more (Economic Times)


  • Japanese expo showcases hi-tech preventive medicine (Reuters)


  • Feast after famine linked to diabetes boom in China (Reuters)

Other International

  • Pfizer may establish production of its drugs in Russia (PharmaLetter-$)
  • New study from Ecuador shows the impressive effect of ivermectin (MNT)
  • Cholera Spreads From Iraq to Syria, Kuwait, Bahrain: UNICEF (Reuters)
  • Guinea Reports 1 New Ebola Case In Infant; Officials Tracking Contacts Of Involved Family (Kaiser)
  • Bayer donates medicines for refugees in Turkey, Greece and Austria (Bayer)

General Health and Other Interesting Articles

  • Should Human Stem Cells Be Used To Make Partly Human Chimeras? (NPR) (STAT)
  • Type 2 diabetes found to have three different subtypes (Pharmaceutical Journal-$)
  • Superbugs mean more infections and deaths after surgery, chemotherapy (Reuters)
  • Scarlet Fever Making a Comeback (DD&D)
  • Living With Cancer: The Lure of Alternative Remedies (NYTimes)

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 @Michael_Mezher or send him an email at

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.

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