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Federal Register Notice: FDA releases a guidance: Acceptability of Draft Labeling to Support ANDA Approval.[ Price : $8.95]
Federal Register Notice: FDA reopens the comment period for a draft guidance on reportable chemistry, manufacturing, and controls ...[ Price : $8.95]
Federal Register Notice: FDA publishes a list of PMAs that have been approved.[ Price : $8.95]
Rothman Institute director Joseph Gulfo suggests a way for FDA to back out of its objection to companies providing truthful and no...[ Price : $8.95]
FDA releases an FDA-483 listing four observations from an inspection at GlaxoSmithKlines Aiken, SC, consumer healthcare facility.[ Price : $8.95]
Bloomberg Business says that an FDA effort to bring old unapproved drugs under modern regulation can lead to much higher prices fo...[ Price : $8.95]
An FDA drug safety review of Zambons Monurol (fosfomycin) finds no new safety signals related to either parenteral or oral formula...[ Price : $8.95]
FDA approves an Alkermes NDA for Aristada (aripiprazole lauroxil) extended-release injectable suspension for treating schizophreni...