The U.S. Food & Drug Administration regulates new drug approvals in a process that is extremely thorough, lengthy and expensive. Regulations apply to a drug candidate's product development phase, the approval process and after approval. Failure to ... JD Supra, 2 days ago
Bedaquiline approved to treat multi-drug resistant tuberculosis - BDlive, 2 days ago
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Many dietary supplements remain on the retail market months after they were recalled by the US Food and Drug Administration (FDA) because they contained banned pharmaceutical ingredients, according to a research letter published in the October 22/29 ...General Medicine eJournal, 16 hours ago Industry Responds to JAMA Letter on Adulterated Supplements Nutraceuticals World, 13 hours ago JAMA Finds Spiked Supplements Still on the Market after FDA Recalls Nutritional Outlook, 21 hours ago Over-the-Counter (OTC) Drugs and Dietary Supplements: Global Markets Biotechgate, 1 week ago
NEW YORK (Reuters Health) - Long after the Food and Drug Administration (FDA) issued recalls for dietary supplements tainted with banned drugs, more than half of the tainted supplements were still available for purchase, a new study found. There's ...Yahoo! India, 1 day ago FDA recalls eight more Ting Hsin Oil products Taipei Times Online, 19 hours ago
NOVARTIS : FDA Advisory Committee Recommends Approval of AIN457 (secukinumab) for Patients with Moderate-to-severe Plaque Psoriasis
Novartis reported the Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) to the US Food and Drug Administration (FDA) voted 7 to 0 to support the approval of AIN457 (secukinumab), a selective interleukin-17A (IL-17A) inhibitor, for the ...4 Traders, 7 hours ago FDA committee unanimously recommends approval of AIN457 for psoriasis treatment Orthopedics Today, 15 hours ago FDA Panel Backs Novartis' Psoriasis Drug RTTNews.com, 2 days ago Novartis: FDA Advisory Committee Recommends Approval of AIN457 (secukinumab) for Patients with Moderate-to-severe Plaque Psoriasis Individual.com, 7 hours ago
A North Carolina drugmaker plans to test its experimental antiviral drug in patients who have Ebola, after getting authorization from regulators at the Food and Drug Administration. Chimerix Inc. said Thursday that it has received FDA clearance ...ABC News, 5 days ago Drug That Lost High-Stakes Political Fight For Funding Now Being Used Against Ebola Huffington Post, 1 day ago FDA Allows Testing of Ebola Experimental Drug by Chimerix American Journal of Managed Care, 5 days ago CBS Health: FDA approves testing new Ebola drug CBS News, 5 days ago
By Kim Rahn The health authorities said Tuesday that its most recent testing of Dongsuh Food's cereal products found no coliform bacteria. Previous tests had found that the company had reused contaminated cereal. Officials at the Ministry of ...Korea Times, 2 days ago Authorities shed light on E. coli fears Joins.com, 1 day ago
US FDA accepts Eisai's sNDA for antiepileptic drug, fycompa to treat primary generalised tonic-clonic seizures
The US Food and Drug Administration (US FDA) has accepted for review the Eisai's supplemental New Drug Application (sNDA)for its in-house developed antiepileptic drug Fycompa (perampanel)for the treatment of primary generalised tonic-clonic seizures ...PharmaBiz, 1 day ago New Inhaled Drug Accredited to Treat Chronic Obstructive Pulmonary Disease Med India, 2 months ago Eisai : U.S. FDA ACCEPTS sNDA FOR ANTIEPILEPTIC AGENT FYCOMPA AS ADJUNCTIVE TREATMENT OF PRIMARY GENERALIZED TONIC-CLONIC SEIZURES 4 Traders, 2 days ago U.S. FDA Grants Priority Review Status to NDA for Anticancer Agent Lenvatinib Drugs.com, 2 days ago
Maharashtra Food and Drug Administration (FDA) has detected over 20 cases of illegal sale of Codeine containing cough syrups to drug addicts in huge quantities without a prescription and without issuing a sales bill. Official reports indicate that ...PharmaBiz, 2 days ago
Regulators from the European Medicines, the US Food and Drug Administration and the UK's Medicines and Healthcare Products Regulatory Agency (MHRA), welcomed the Drug Shortages Prevention Plan, which was released by the International Society for ...Pharma Letter, 6 days ago ISPE Plan to Prevent Drug Shortages released at Annual Meeting Review Seeker, 1 week ago ISPE Releases Drug Shortages Prevention Plan Pharmaceutical Online, 6 days ago ISPE launches plan to prevent drug shortages Manufacturing Chemist, 1 week ago
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As an AIDS activist in the early 1990s, Gregg Gonsalves traveled to Washington to challenge the Food and Drug Administration. Gonsalves was part of the confrontational group AIDS Coalition to Unleash Power, which staged protests outside the FDA's ...Sify, 2 months ago
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