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Federal Register notice: FDA announces that OMB has approved six information collections.[ Price : $8.95]
Federal Register notice: FDA seeks comments on an information collection extension entitled Medical Product Communications That Ar...[ Price : $8.95]
Pfizer and BioNTech begin a rolling BLA to seek full approval of their mRNA vaccine to prevent Covid-19 in individuals 16 years of...[ Price : $8.95]
Federal Register notice: FDA sends to OMB and information collection extension entitled Class 2 Special Controls Guidance Document...[ Price : $8.95]
An FDA advisory committee splits on whether the efficacy data support approval for a ChemoCentryx NDA for avacopan targeting anti-...[ Price : $8.95]
FDA grants Viome a breakthrough device designation for its proprietary mRNA analysis technology combined with its artificial intel...[ Price : $8.95]
FDA releases the FDA-483 with 10 observations issued following an inspection six months ago at Hospiras sterile drug manufacturing...[ Price : $8.95]
Federal Register notice: FDA sends to OMB an information collection extension entitled 513(g) Request for Information for device c...