Regulatory Focus™ > News Articles > Regulatory Reconnaissance: FDA to Public: Stop Taking Ultrasound Selfies of Your Fetus (19 March 201

Regulatory Reconnaissance: FDA to Public: Stop Taking Ultrasound Selfies of Your Fetus (19 March 2014)

Posted 19 March 2014 | By Alexander Gaffney, RAC

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In Focus: US

  • FDA Wants You to Stop Taking Ultrasound Selfies of Your Unborn Kids (WebMD)
  • CDRH Cardiovascular Branch Chief Sonna Patel-Raman Leaves for Industry (Press)
  • FDA rejects Avedro's ophthalmic drug-device (SCRIP-$) (BioCentury) (Fierce) (Mass Device) (Clinica-$)
  • Social media: a goldmine and a minefield for biopharma (BioWorld)
  • FDA Reduces GMP Inspections by 40 Percent, Focuses on Imports (PharmaManufacturing)
  • On Data Sharing, Pharmaceutical Companies Finally Open Up (WSJ-$)
  • Snowball Effect: The Incidence of Premature Paragraph IV Certification Notice Grows (FDA Law Blog)

In Focus: International

  • Industry worried "genetic resources" rules will slow flu vaccine production (In-Pharma)
  • Detailed analysis of EMA's new Guideline on Process Validation (ECA)
  • Industry on tenterhooks over Indian trial compensation (SCRIP-$)

US: Pharmaceuticals/Biotechnology

  • Social media: a goldmine and a minefield for biopharma (BioWorld)
  • FDA Reduces GMP Inspections by 40 Percent, Focuses on Imports (PharmaManufacturing)
  • On Data Sharing, Pharmaceutical Companies Finally Open Up (WSJ-$)
  • Noven: Our Patch Problems Should Be Everyone's Patch Problems (Pink Sheet-$)
  • Primatene HFA Turned Down By FDA Panel; Will Capitol Hill Accept Decision? (RPM Report-$)
  • Snowball Effect: The Incidence of Premature Paragraph IV Certification Notice Grows (FDA Law Blog)
  • New Jersey Introduces Biosimilar Substitution Bill (SCOUT)
  • FDA Hammers Columbia Doc's Clinical Trial Oversight (Law 360-$) (FDA)
  • Agile SEC filing reveals FDA rejection for Twirla contraceptive (SCRIP-$)
  • Hospira Announces Voluntary Nationwide Recall of Hemoset Blood Set (FDA) (FDA)
  • Zohydro's Chances Of Staying On The Market (Seeking Alpha)
  • Panel Urges Higher Bar for Cancer Trials (MedPage Today)
  • CBER Looking for new Chief for its Blood and Plasma Branch (FDA)

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

US: Pharmaceuticals and Biotechnology: General

  • Casey urges Congress to prevent prescription drug abuse (The Hill)
  • Gov't approves study of marijuana smoking to treat PTSD in military veterans (CBS)
  • Is Belphen the Next Blockbuster Diet Drug? (MedPage Today)
  • Antitrust Group Backs Cipro Buyers In Pay-For-Delay Row (Law 360-$)

US: Medical Devices

  • FDA Wants You to Stop Taking Ultrasound Selfies of Your Unborn Kids (WebMD)
  • CDRH Cardiovascular Branch Chief Sonna Patel-Raman Leaves for Industry (Press)
  • FDA rejects Avedro's ophthalmic drug-device (SCRIP-$) (BioCentury) (Fierce) (Mass Device) (Clinica-$)
  • FDA: Medical Device Reporting Electronic Submission Requirements (Policy and Medicine)
  • What medical device companies should consider before outsourcing to an FDA registered contract manufacturer (Mass Device)
  • Exact Sciences' Colon Cancer Test Detects More Tumors (Bloomberg)
  • Class 1 Recall for Abbott's FreeStyle Flash Blood Glucose Monitors (FDA) (FDA)
  • Breast Pump Recall Due to Potential for Electric Shock (FDA)
  • Teleflex scores pivotal FDA clearance for expanded use of its vascular system (Fierce)
  • Thoratec updates HeartMate II controller warning (Mass Device)
  • Volcano Announces FDA Clearance of its Proprietary iFR (instant wave-Free Ratio) Modality (Press)
  • Summary of the 14 March 2014 Ophthalmic Devices Panel Meeting  (FDA)
  • December 2013 PMA Approvals (FDA)

US: Dietary Supplements

  • Kratom distributor recalls all products in wake of FDA import alert (NI-USA)

Europe

  • Industry worried "genetic resources" rules will slow flu vaccine production (In-Pharma)
  • Detailed analysis of EMA's new Guideline on Process Validation (ECA)
  • St. Jude Medical will test its leadless pacemaker in a massive EU post-marketing trial (Fierce) (Mass Device)
  • 'More transparency' needed from pharma, says NICE (Pharmafield)
  • Allergan reprimanded over Botox promotion (Pharmafile)
  • Medrobotics Corporation Receives CE Mark for the Flex System (Press)

India

  • Industry on tenterhooks over Indian trial compensation (SCRIP-$)
  • Delhi High Court Blocks Wockhardt From Launching Novartis' Galvus Copies (Pink Sheet-$)
  • Indian drugmakers ponder opening plants in U.S., Europe (Fierce)

Other International

  • Industry Proposals for Addressing Post-Approval Change Burdens Include Harmonizing on Commitments and Classifications (ECA)
  • Pakistan Drug Firms Note Lower Investment As Regulatory Policy Wavers (PharmAsia-$)

General Regulatory And Interesting Articles

  • Astellas Pharma and Daiichi Sankyo Form Compound Library Sharing Partnership (Press)
  • An End to Animal Testing for Drug Discovery? (Press)
  • Sleuths use hi-tech sensors to fight pharmaceutical crime (Astellas)

Regulatory Reconnaissance #279 - 19 March 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.


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