Drug Safety

Latest Headlines

Latest Headlines

UPDATED: FDA agrees to review Pfizer's abuse-deterring opioid candidate

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.

Another doctor convicted for selling foreign-made drugs

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.

Tear up the rules and start again, Lancet panel says to India on drug safety

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.

Report: 'Carrot and stick' needed to deal with drug shortages

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.

China FDA orders respiratory API recalled after 'fur' like impurities found

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.

Pet tear-stain removers still widely available despite FDA warnings

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.

India's Wockhardt says it has addressed U.S. FDA compliance issues at Illinois plant

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.

U.K. regulators shut down plant making potentially contaminated drug

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.

U.S. FDA plans to double drug inspectors in India as marketing applications soar

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.

Pakistan struggles to fill top spot at drug regulator as woes mount for industry

SINGAPORE-- Sometimes it must seem to Pakistan's health authorities they can do nothing right in regulating the nation's pharmaceutical industry.