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FDA posts a guidance on Clinical Considerations for Investigational Device Exemption (IDEs) for Neurological Devices Targeting Dis...[ Price : $8.95]
New CDER review documents embedded in a just-released approval package for Sareptas controversial Duchenne drug Exondys 51 (etepli...[ Price : $8.95]
Sen. Bernie Sanders (I-VT) and Rep. Elijah Cummings (D-MD) ask the Justice Department and the Federal Trade Commission to investig...[ Price : $8.95]
CDRH introduces a new program on the Patient and Care-partner Connection to allow patients and their organizations to dialog with ...[ Price : $8.95]
Lupin says it has resolved GMP deficiencies cited by FDA during an inspection in March at its Goa, India manufacturing plant.[ Price : $8.95]
FDA grants AbbVie an Orphan Drug Designation for veliparib, an oral poly (adenosine diphosphate-ribose) polymerase (PARP) inhibito...[ Price : $8.95]
Law school professor Christopher Robertson and medical school professor Aaron Kesselheim urge FDA to continue to stand on principl...[ Price : $8.95]
CDERs Office of Prescription Drug Promotion notifies Supernus Pharmaceuticals that a Spanish-language video for its Oxtellar XR mi...