Pharma bigwig Pfizer announced that the FDA has agreed to review the New Drug Application of its abuse-deterring extended-release opioid capsules, dubbed ALO-02.
Federal authorities have extracted another guilty plea from a doctor found to be using unapproved foreign versions of drugs on his patients, including Rituxan, Remicade and Prolia. The Kentucky physician, who bought the drugs at a deep discount from the U.K., will pay more than half a million dollars in restitution and has received a year of probation.
SINGAPORE-- One of the world's most prestigious medical journals called for India to abandon its current proposal to change the way it regulates drugs and come up with a new plan.
Canada will now require drugmakers to report drug shortages, a practice that has been voluntary. But a new report from Pew Charitable Trusts says solving the problem of drug shortages will require a multipronged attack by regulators, payers and the industry.
SINGAPORE-- The China FDA ordered Shangdong Qidu Pharmaceutical to recall 21,700 bottles of an injectable API combination for treating respiratory, urinary and reproductive infections. The agency said impurities "similar to furs" were found in sampled bottles.
The extreme cold gripping the country is likely causing a lot of watery eyes, not just in people, but in dogs, too. In some breeds, excess tearing can result in brownish stains under the eye--a common condition that has prompted several companies to market products meant to erase those marks.
SINGAPORE-- Wockhardt's chairman told reporters the company's Illinois production plant, responsible for half its sales in the United States, has taken care of the issues that led the FDA to issue it a Form 483 citing compliance failures last year.
Regulators in the U.K. have closed down a manufacturing operation there that was making unapproved, unlicensed globulin component macrophage activating factor, a blood product which has the potential to stimulate macrophages to kill cancer cells and stimulate the immune system but is not yet approved for use.
The U.S. FDA is hiring new inspectors in India to tackle the high rate of marketing applications made by local firms, an agency official said.
SINGAPORE-- Sometimes it must seem to Pakistan's health authorities they can do nothing right in regulating the nation's pharmaceutical industry.