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PDUFA date. In United States pharmaceutical regulatory practice, the PDUFA date is the colloquial name for the date by which the Food and Drug Administration must respond to a New Drug Application or a Biologics License Application. [1] It is part of the regime established by the Prescription Drug User Fee Act to ensure funding of the Food and ...
In July 2021, the U.S. Food and Drug Administration (FDA) granted priority review designation for the biologics license application (BLA) for the Pfizer–BioNTech COVID-19 vaccine with a goal date for the decision in January 2022. [276] [277] On 23 August 2021, the FDA approved the vaccine for use for those aged sixteen years and older. [33 ...
National regulatory authorities have granted full or emergency use authorizations for 40 COVID-19 vaccines.. Ten vaccines have been approved for emergency or full use by at least one stringent regulatory authority recognized by the World Health Organization (WHO): Pfizer–BioNTech, Oxford–AstraZeneca, Sinopharm BIBP, Moderna, Janssen, CoronaVac, Covaxin, Novavax, Convidecia, and Sanofi ...
On 18 December 2020, the US FDA granted an EUA for mRNA-1273, the Moderna vaccine. [26] [27] [28] Vaccine manufacturers are awaiting full approvals to name their vaccines. [117] [118] Moderna submitted a request for an EUA for mRNA-1273 to the FDA on 30 November 2020. [119] [120] On 18 December 2020, the FDA granted an EUA for the Moderna ...
The biologics license application is a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce (21 CFR 601.2). The BLA is regulated under 21 CFR 600 – 680. A BLA is submitted by any legal person or entity who is engaged in manufacture or an applicant for a license who takes responsibility ...
In 1832 produced chloral hydrate, the first synthetic sleeping drug. In 1833 French chemist Anselme Payen was the first to discover an enzyme, diastase. In 1834, François Mothes and Joseph Dublanc created a method to produce a single-piece gelatin capsule that was sealed with a drop of gelatin solution.
The Janssen COVID‑19 vaccine, (Ad26.COV2.S) sold under the brand name Jcovden, [1] is a COVID‑19 vaccine that was developed by Janssen Vaccines in Leiden, Netherlands, [24] and its Belgian parent company Janssen Pharmaceuticals, [25] a subsidiary of American company Johnson & Johnson. [26][27][28] It is a viral vector vaccine based on a ...
In March 2020, the Food and Drug Administration approved clinical trials for the Moderna COVID‑19 vaccine candidate, and in December, the vaccine, mRNA-1273, was issued an emergency use authorization in the United States. [34] [35] In 2022, it gained FDA approval both for the monovalent vaccine, Spikevax, and a bivalent booster. [36]