February 17, 2018 Drug & Device Advisory Group Link and Learn CDC- Public Health Image Library 2014 image depicting CDC microbiologist Valerie Albrecht, as she was holding up for observation, two Petri dish culture plates that had been inoculated with methicillin-resistant Staphylococcus aureus (MRSA) bacteria CDC-PHIL Share this: Email Print WhatsApp Like this: Like Loading… Published …
April 26, 2020 Drug & Device Advisory Group FDA Briefs Word of Thanks from FDA Commissioner FDA Commissioner Stephen M. Hahn, M.D.thanks our nation’s essential workforce as well as the nation’s population for their efforts to combat COVID-19 Watch Share this: Email Print WhatsApp Like this: Like Loading… Published by Drug & Device Advisory Group …
February 11, 2019 Drug & Device Advisory Group FDA Briefs News & Views: Patients First, Least Burdensome Provisions, Drug Supply Chain security, 510(K) exemptions FDA’s Patient Affairs Staff (PAS)- FDA Puts Patients First PAS works with patients, caregivers, and advocates in 2019 Understanding patient experience and incorporating patient feedback into FDA’s work PAS launched several initiatives …
August 12, 2016 Drug & Device Advisory Group Link and Learn MedSun WHAT: Work collaboratively with a network of 250 hospitals, nursing homes and home health facilities in US WHO: CDRH WHY: To assist in detecting, understanding, and sharing information on safety of devices WHEN: Launched in 2002 HOW: Secure, on-line system for reporting problems …
March 17, 2021 Drug & Device Advisory Group FDA Briefs News and Views: Fraudulent FDA ‘registered’ products, Reporting misconduct, Data modernization plan, Real World Evidence for regulatory decision making FDA Registered” or “FDA Certified” Medical Devices are not FDA approved Misleading website claims of FDA Registered, FDA Certified, FDA Registration Certificate aometimes along with FDA …
January 4, 2020 Drug & Device Advisory Group Link and Learn e-cigarettes: Enforcement policy on unauthorized flavored cartridges Enforcement policy on unauthorized flavored cartridge-based e-cigarettes that appeal to children, including fruit and mint FDA intends to prioritize enforcement against these illegally marketed ENDS products by focusing on the following groups of products that do not …
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February 15, 2016 Drug & Device Advisory Group FDA Briefs FDA Approval of Sernivo FDA Brief: Week of Feb 8, 2016 Sernivo (betamethasone dipropionate) Spray, 0.05% Promuis Pharma, Princeton, New Jersey, USA Indication: treatment of mild to moderate plaque psoriasis in patients 18 years of age or older. Reg Pathway: 505 …
January 8, 2017 Drug & Device Advisory Group FDA Briefs FDA VOICE: CDER 2016 Approvals, Medical Device Cybersecurity FDA BRIEF: Week of December 26th, 2016 and January 2nd, 2017 A Review of CDER’s Novel Drug Approvals for 2016 By: John Jenkins, M.D., Director of the Office of New Drugs, CDER Approved 22 novel drugs FIRST: …
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December 20, 2018 Drug & Device Advisory Group Link and Learn Patients Matter and Patient Engagement Patient Engagement Individual patient experience diseases and therapies differently has unique perspective about treatments or diagnostic procedures Opportunities for patients and caregivers to get involved with FDA Evolution of Patient Engagement at FDA Patient Engagement Collaborative FDA and European …
August 29, 2017 Drug & Device Advisory Group Link and Learn FDARA & User Fees FDARA and FDA User Fee Programs President signed into law the Food and Drug Administration Reauthorization Act (FDARA) Revises and extends FDA’s user-fee programs for prescription drugs (PDUFA), medical devices (MDUFA), generic drugs (GDUFA) and biosimilar (BsUFA) products Provides FDA …
