FDA News and Views: 2017 Reauthorization Act, FDA Workforce, STEM Education, Grapefruit Interaction, Medical Device Standard Recognition – Drug and Device Digest

FDA BRIEF: Week of July 17, 2017


The Committee on Energy and Commerce extended user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products

Devices

  • new user fees for de novo medical device classification requests
  • pilot program to audit and certify laboratories for device conformance testing
  • flexibility to better assess device types most appropriate for third-party review
  • all device submissions in electronic format by 1 October 2021
  • risk-based inspection of medical device establishments
  • establish standards to improve predictability for scheduled inspections
  • process for issuance of foreign export certificates
  • regulations to establish category of over-the-counter hearing aids
  • ensure  quality, safety and effectiveness of services devices
  • voluntary pilot program for device manufacturers for postmarket study requirements using active surveillance
  • classification of medical device accessories based on intended use
  • approval of imaging device with use of contrast agent

Prescription Drugs

  • raises penalties for counterfeit and illegally diverting drugs
  • engage with Congress to lower the cost of prescription drugs
  • recognize foreign government auditors to improve international inspection
  • clarify qualifying criteria for neglected tropical diseases priority review voucher
  • reauthorize critical path public-private partnership for five years

FDA Authorization Act of 2017


Audience Participating in Scientific Professional Development Lecture

Building a Strong FDA Workforce to Bring Scientific Advances to Patients

By: Scott Gottlieb, M.D., Commissioner 

FDA staff must remain current with dramatic advances in science and medicine

  • need for diverse, talented, and dedicated professional workforce
  • requested comprehensive evaluation of  hiring practices and procedures
  • critical to modernize process for recruiting personnel

Piloting new hiring procedures headed by Melanie Keller, Office of Management, CDER

  • align administrative hiring procedures and scientific staffing objectives
  • reflect scientific objectives of review programs in recruitment and hiring
  • prioritize hiring into positions supported by PDUFA commitments

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Dr. Rick Pazdur and Members of Summer Scholars

Leveraging FDA Resources to Encourage Students to Pursue STEM Careers

By: Richard Pazdur, M.D., Director, FDA Oncology Center of Excellence

Oncology Center of Excellence recently launched pilot Summer Scholars Program

  • to introduce high-school students to oncology drug development
  • 11 Washington, D.C., area HS students to FDA’s Silver Spring campus for six weeks
  • curriculum: basic and translational science, drug manufacturing, clinical trials, regulatory review, patient advocacy, and marketing

The OCE Summer Scholars Program could be expanded next year to high school students nationally

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Grapefruit Juice Drug Overdose Info-graphic (800x237)

Grapefruit Juice Drug Under-dose Info-graphic (800x237)

Grapefruit Juice and Some Drugs Don’t Mix

Grapefruit juice interacts with some drugs:

  • statin drugs to lower cholesterol: Zocor (simvastatin), Lipitor (atorvastatin)
  • to treat high blood pressure: Procardia and Adalat CC (both nifedipine)
  • organ-transplant rejection drugs: Sandimmune and Neoral (both cyclosporine)
  • anti-anxiety drugs: buspirone
  • corticosteroids to treat Crohn’s disease or ulcerative colitis: Entocort EC and Uceris (both budesonide)
  • to treat abnormal heart rhythms: Pacerone and Nexterone (both amiodarone)
  • antihistamines: Allegra (fexofenadine)

Severity of the interaction dependent on the person, the drug, and the amount of grapefruit juice

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Recognition of a Medical Device Standard

The 21st Century Cures Act of 2016 clarifies how FDA will process requests for recognition of voluntary consensus standards:

  • 60-day timeframe for FDA response to recognition requests
  • FDA response in writing
  • FDA publication of rationale for recognition of all, part, or none of standard

READ


Image Credit: FDA

 

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