Topic:

Regulatory

Latest Headlines

Latest Headlines

Japan's PMDA sets 12-month target on drug, device reviews with domestics favored

Japan's Pharmaceuticals and Medical Devices Agency (PMDA) aims to accelerate high-quality drug and medical device reviews to 12 months for at least 70% of new drugs filed for approval with domestic firms favored, according to its steering committee meeting on March 10.

India and China gear up for trade talks with a pharma focus

Beijing and New Delhi plan ministerial-level trade discussions to tackle pharmaceutical and four other major issues involving services and products that India can supply to China, according to an India official.

India plans adverse effects monitoring regime for medical devices

India's health ministry has plans to create the nation's first system for monitoring the adverse effects of medical devices. Up to now, health authorities have relied on data supplied by the world's developed countries.

Another strike against Merck's sugammadex as FDA nixes advisory panel confab

Merck & Co. says it's expecting yet another rejection from the FDA for its anesthesia drug sugammadex, as the agency scrapped an advisory panel's review of the drug slated for next week. The FDA told the company it plans additional site inspections before it hands the info over to an advisory committee.

Boston Sci's stroke-fighting Watchman overcomes years of regulatory roadblocks, wins FDA approval

Boston Scientific finally won FDA approval for its stroke-fighting Watchman device after setbacks or rejections in 2010 and 2014. The device was approved for patients with an appropriate rationale to seek a nonpharmacologic alternative to the blood thinner warfarin. The FDA's blessing follows a multiyear clinical trial of 2,400 patients.

India and U.S. scientists battle over virulence of swine flu strain in India

Scientists in India and the United States are doing battle over whether the H1N1 swine influenza virus has mutated into a strain more virulent than the one that has killed at least 1,700 people in India this year.

USDA head calls halt to any new experiments at Nebraska facility

The Secretary of Agriculture has halted all new experimental projects at the U.S. Meat Animal Research Center in Nebraska until the facility beefs up its procedures and oversight protocols.

China FDA draft rules seek detailed tracking data for exported medical devices

The China FDA has released for comment a draft regulation covering exports of medical devices. The draft would require a slew of records covering the equipment so officials can track fraudulent data and production and exporting methods.

New FDA report finds banned antibiotics still showing up in dairy cow tests

According to a new report by the FDA, some farmers continue to use antibiotics that routine tests don't detect, especially in dairy cows, because those drugs are banned.

USDA to launch national equine study this spring

The U.S. Department of Agriculture is launching a new study in May that focuses on the country's equine industry. Dubbed "Equine 2015," the study is a follow-up to the agency's National Animal Health Monitoring Systems' previous reports on the industry conducted in 1998 and 2005.