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Cybersecurity in Medical Devices: Definitions from FDA’s Draft Guidance

Compensating Controls: “A safeguard or countermeasure, external to the device, employed by a user in lieu of, or in the absence of sufficient controls that were designed in by a device manufacturer, and that provides supplementary or comparable cyber protection for a medical device.” Controlled Risk: “Present when there is sufficiently low (acceptable) residual risk […] READ MORE...


Obtaining IND-Related Feedback from FDA

What to do if you experience delays in obtaining IND-related feedback from the FDA: In December 2015, the FDA released a draft guidance, which provides IND sponsors with a number of recommendations and best practices for communicating with the FDA. In addition, the draft guidance also states that although it strives to adhere to all […] READ MORE...


Best Practices for Meeting-Related Communication with FDA

In December 2015, the FDA released a draft guidance, which provides IND sponsors with a number of recommendations and best practices for communicating with the FDA.  Among those included in the draft guidance are the following best practices for meeting-related communication with FDA: Meeting Requests: Before requesting a meeting with FDA, sponsors should use the […] READ MORE...


FDA’s Center for Drug Evaluation & Research: 2016 Priorities

FDA’s Center for Drug Evaluation & Research (CDER) 2016 Priorities & Areas of Focus Front Burner Priorities: Negotiate PDUFA 6 agreements Negotiate GDUFA 2 agreements Negotiate a second BSUFA program Continue to implement new (and clarified) statutory provisions on drug compounding and outsourcing facilities Continue to meet milestones of Sunscreen Innovation Act Continue implementation of […] READ MORE...


FDA’s Center for Drug Evaluation & Research: 2015 Priorities & Accomplishments

FDA’s Center for Drug Evaluation & Research (CDER) 2015 Priorities & Accomplishments Front Burner Priorities: GDUFA: meeting and exceeding performance goals; confident the division can reach steady state in two years Stabilization of new Office of Generic Drugs: accomplished Standup of Office of Pharmaceutical Quality: completed Completion of 2015 PAG agreement work: done Pharmacy compounding: […] READ MORE...