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

READ


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

READ


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

READ


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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