FDA Archives – RamaOnHealthcare

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FDA finalizes PHE transition plan for medical devices

FDA details plan to end emergency use authorizations

FDA releases transition plans for medical device enforcement, authorization after COVID-19 public health emergency

Matthew’s health care tidbits: The drug model for DTx was wrong

New Life In Drug Importation

FDA outlines plan for digital health technologies for clinical trials

Research guides FDA action on common medical device

Public Health Messages And The First Amendment: Graphic Warning Labels Struck Down

FDA to end some COVID-19 policies, revise others for long-term guidance

FDA staff says Biogen's ALS drug may have a 'clinical benefit' on a rare form of the disease

HHS: FDA COVID-19 emergency use authorizations remain in effect

FDA offers radio silence on question of spring Covid boosters, as other countries push ahead

FDA updates guidance on use of EHRs, digital tools in clinical trials

FDA Announces Impact of Ending COVID-19 Public Health Emergency

FDA's Califf calls on insurers to help providers participate in critical clinical drug trials

A Challenging Regulatory Environment Means More Care Needed with FDA Submissions

FDA to withdraw certain drug-related guidances with end of PHE

Challenges to the FDA’s Approval of Medication Abortion Pills Could Curtail Access Throughout the United States

FDA issues breast density reporting mandate, but supplemental screening still out of reach for many

Four Things that Healthcare Providers Need to Know About FDA Counterfeiting Investigations

Legal Challenges to the FDA Approval of Medication Abortion Pills

FDA unveils major new changes to its mammography quality standards regulations, and mandates reports to patients about their breast density

Eroding Judicial Deference to the FDA — Consequences for Public Health

HHS Leverages Data for Impact and Action at the 2023 Health Datapalooza

Govt Agencies: FDA