Regulatory Affairs Syndicator

BEIJING, Dec 1 Asia Pulse - China’s State Food and Drug Administration has recently issued new rules regarding the management of record filing for accepting foreign orders for drug process on a commissioned basis, which will come into effect as of January 1, 2006.

CHICAGO (Reuters) - Teva Pharmaceutical Industries Ltd. on Wednesday said it won tentative approval from the U.S. Food and Drug Administration to sell 5 mg and 10 mg Zaleplon Capsules, a short-term treatment for insomnia.

Novartis Pharmaceuticals Corporation has received an approval from the US Food and Drug Administration for Trileptal (oxcarbazepine) tablets and oral suspension as adjunctive therapy (use in combination with other antiepileptic drugs) in the treatment of partial seizures in children as young as two-years old with epilepsy.

Roche and Trimeris have received an approvable letter from the US Food and Drug Administration, in response to their request for inclusion of information about the Biojector 2000 (B2000) needle-free injection device in the Fuzeon (enfuvirtide) labelling.

Mylan Pharmaceuticals Inc. has received final approval from the US Food and Drug Administration for its abbreviated new drug application (ANDA) for glimepiride tablets, 1 mg, 2 mg, and 4 mg.

By Karla GaleNEW YORK (Reuters Health) - Since the US Food and Drug Administration approved mifepristone and misoprostol as abortion-inducing drugs in 2000, there have been four deaths due to profound shock caused by a bacterium called Clostridium sordellii, investigators report.With this type of “medical abortion,” patients are instructed to swallow a mifepristone pill and then a day or two

By Karla Gale NEW YORK (Reuters Health) - In April, the US Food and Drug Administration issued an advisory that the use of atypical antipsychotics increases mortality in elderly persons with dementia, but now investigators report that conventional antipsychotic medications may be even more dangerous. “If confirmed,” Dr.

India has topped the list for rejected food and drug export consignments to the US, Rajya Sabha was informed on Wednesday.

Health / Pharmaceuticals India has topped the list for rejected food and drug export consignments to the US, Rajya Sabha was informed on Wednesday.

WASHINGTON, Nov. 30 (UPI) — The Food and Drug Administration is warning consumers of eye drops and pain relievers made by MBI or Molecular Biologics to stop using the products.

RU486: Don’t go thereOn Line opinion, Australia - 55 minutes ago… In women of childbearing age lethal infections caused by C. sordellii were rare prior to the Food and Drug Administration’s approval of RU486. … Debating the ‘aborti…

RU486: Don’t go thereOn Line opinion, Australia - 14 hours ago… In women of childbearing age lethal infections caused by C. sordellii were rare prior to the Food and Drug Administration’s approval of RU486. …

In April, the US Food and Drug Administration issued an advisory that the use of atypical antipsychotics increases mortality in elderly persons with dementia, but now investigators report that conventional antipsychotic medications may be even more dangerous.

Since the US Food and Drug Administration approved mifepristone and misoprostol as abortion-inducing drugs in 2000, there have been four deaths due to profound shock caused by a bacterium called Clostridium sordellii, investigators report.

FDA Tentatively OKs Teva Insomnia DrugMSN Money - 2 hours agoNEW YORK (AP) - Teva Pharmaceutical Industries said on Wednesday it received tentative approval from the Food and Drug Administration to sell its 5 milligram … Teva Announces Tentativ…