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Federal Register notice: FDA seeks comments on a petition from an undisclosed applicant requesting exemption from premarket notifi...[ Price : $8.95]
Federal Register notice: FDA makes available a guidance on Same Surgical Procedure Exception under 21 CFR 1271.15(b): Questions an...[ Price : $8.95]
Federal Register notice: FDA makes available a guidance entitled Regulatory Considerations for Human Cells, Tissues, and Cellular ...[ Price : $8.95]
A new White House report estimates that the ongoing opioid crisis cost the U.S. $504 billion in 2015 and led to over 33,000 Americ...[ Price : $8.95]
Federal Register notice: FDA acknowledges that an applicant for a proposed biosimilar product notified the agency that a patent in...[ Price : $8.95]
Federal Register notice: FDA makes available a guidance entitled Unique Device Identification: Direct Marking of Devices.[ Price : $8.95]
FDA approves a Kalo supplemental NDA for AUVI-Q (epinephrine injection, USP) 0.1 mg, for treating life-threatening allergic reacti...[ Price : $8.95]
FDA grants PellePharm a breakthrough therapy designation and orphan drug designation for topical patidegib for patients with Gorli...