18 Jan, 2023 FDORA implements new FDA requirements for foreign drug and medical device companies By Melissa Gilmore On December 29, 2022, President Biden signed the Consolidated Appropriations Act, 2023 into law, which contains the Food and Drug Omnibus...
10 Jan, 2023 FDA denies requests for revocation of EUA for COVID vaccine for use in individuals 5-11 and 12-17 years of age By Melissa Gilmore The FDA has denied two citizen petitions filed on behalf of the Informed Consent Action Network (ICAN) requesting the agency revoke its...
19 Dec, 2022 FDA Denies Requests for Revocation of EUA for Covid Vaccine for Use in Individuals 5-11 and 12-17 Years of Age By Melissa Gilmore Jarred Reiling Keo Shaw The FDA has denied two citizen petitions filed on behalf of the Informed Consent Action Network (ICAN) requesting the agency revoke its...
04 Mar, 2022 The beginning of the end: FDA details roadmap to terminating COVID-19 EUAs and enforcement policies for medical devices, PPE By Melissa Gilmore In late February, 2022 the US Food and Drug Administration (FDA) hosted a webinar detailing its current transition plans for medical...