US Authorities Fines Indian Generic Drug Giant Ranbaxy (Dolla...

US Food and Drug Administration (FDA) has now issued guidance on Regulatory Classification of Pharmaceutical Co-Crystals. It provides applicants of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) on the required data to be ...

By Joy Lee, The China PostTAIPEI, Taiwan -- The Food and Drug Administration (FDA) yesterday said local health departments have taken over investigations after the unapproved food material maleic acid ( 丁烯二酸) was found in five of 74 popular ...

State pharmacy officials on Thursday threw their support behind a proposal giving the Food and Drug Administration authority over large compounding pharmacies, in an effort to head off more

SPA -- Prince Khalid bin Bandar bin Abdulaziz, Governor of Riyadh region, received here today Executive President of Saudi Food and Drug Authority Dr. Mohammed bin Abdulrahman Al-Mishaal. During the meeting, the Prince was briefed on the Authority's ...

WASHINGTON — A top official with the U.S. Food and Drug Administration warned Thursday that another deadly meningitis outbreak like the one that sickened hundreds of people nationwide and killed 15 people in Tennessee last year could happen again ...

The Food and Drugs Authority (FDA) has alerted the public of fake Coartem tablets in circulation in some Western and Central African countries. Coartem is a registered antimalarial medicine manufactured by Novartis. According to the FDA, although an ...

Janssen Research & Development, LLC (Janssen) announced today that the U.S. Food and Drug Administration (FDA) has granted Priority Review to the New Drug Application (NDA) for simeprevir (TMC435), an investigational NS3/4A protease inhibitor ...

Merck ( MRK ) recently announced that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for its ragweed pollen (ambrosia artemisiifolia) sublingual allergy immunotherapy tablet.Merck's Timothy grass ...

The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the FDA Draft Plan on Structured Approach to Benefit-Risk Assessment in Drug Regulatory Decision Making. BIO ...