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Strabismus Detection Device Into Class 2

[ Price : $8.95]

Federal Register Final Order: FDA classifies the strabismus detection device into Class 2 (special controls).

FDA to Help With Legislation to Curb Generic Drug Delays

[ Price : $8.95]

CDER director Janet Woodcock says the agency is interested in providing technical expertise on legislation that could curb brand n...

FDA Fast Track Status for Malaria Vaccine

[ Price : $8.95]

FDA grants Sanaria a fast track designation for its preventative vaccine for malaria, Sanaria PfSPZ Vaccine.

CGMP Violations in Hebei Yuxing Inspection

[ Price : $8.95]

FDA warns Hebei Yuxing Bio-Engineering about CGMP deviations in its manufacturing of active pharmaceutical ingredients, and places...

FDA Lab Test Proposal is Double Regulation: Senator

[ Price : $8.95]

Sen. Lamar Alexander criticizes an FDA proposal to regulate all laboratory-developed tests now regulated under the Clinical Labora...

CDER Office of Surveillance and Epidemiology MAPP

[ Price : $8.95]

CDER issues a MAPP with procedures the Office of Surveillance and Epidemiology follows when it reviews proposed drug proprietary n...

Draft Guidance on Determining When REMS is Necessary

[ Price : $8.95]

Federal Register Notice: FDA posts a draft guidance entitled FDAs Application of Statutory Factors in Determining When a REMS Is N...

House Committee Leaders Want OCI Update

[ Price : $8.95]

Leaders of the House Energy and Commerce Committee ask FDA for extensive updated information on the agency Office of Criminal Inve...

Adverse Events Unreported in Published Studies: Research

[ Price : $8.95]

Researchers say they found that a significant amount of adverse event data is not reported in published reports of clinical trials...

FDA Clears K2M Groups Spinal Screws/Connectors

[ Price : $8.95]

FDA clears a K2M Group Holdings 510(k) for screw and connector components for a spine application used with its MESA Spinal System...