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Federal Register Notice: FDA announces the availability of a draft guidance entitled Coordinated Development of Antimicrobial Drug...[ Price : $8.95]
Federal Register Notice: FDA releases a guidance entitled Reporting of Computational Modeling Studies in Medical Device Submission...[ Price : $8.95]
Federal Register Notice: FDA announces a publication containing modifications to the agencys list of standards it recognizes for u...[ Price : $8.95]
FDA approves a Janssen Pharmaceuticals supplemental NDA for Invokamet XR (canagliflozin and metformin hydrochloride) for first-lin...[ Price : $8.95]
The 16 member organizations of the Patients Alliance for Drug Safety Protections caution that proposed legislation could weaken FD...[ Price : $8.95]
Federal Register Notice: FDA suspends approval of an Armenpharm, Ltd. ANDA for chloramphenicol capsules, 250 mg because previous v...[ Price : $8.95]
The 2nd Circuit Appeals Court says that the fact that FDA cleared a home pregnancy test with specific instructions on how it is to...[ Price : $8.95]
FDA clears a Heidelberg Engineering 510(k) to market its Spectralis OCT Glaucoma Module Premium Edition that is intended to provid...