Topic:

Regulatory

Latest Headlines

Latest Headlines

FDA issues warning letter to Smith & Nephew regarding questionable operations at plant in Andover, MA

The FDA slapped Smith & Nephew with a warning letter for quality-control violations at its Andover, MA, facility related to problems with some of the company's mechanical morcellators for removal of intrauterine tissue. The company has placed a hold on shipments of its Truclear Ultra Reciprocating Morcellator 4.0 while it further investigates customer complaints.

Startup Transcend to submit PMA in second half for glaucoma micro-stent after positive pivotal data

Venture-backed startup Transcend Medical is expecting to submit a PMA for its novel minimally invasive glaucoma surgical implant during the next half of the year. The move comes after the company garnered positive pivotal data, which it has just released.

India's Torrent buys family-owned Zyg, gains FDA-approved plant

India's Torrent Pharmaceuticals said it has bought all of family-run Zyg Pharma in a deal that gives it access to a new product line in dermatology and a manufacturing facility approved by the U.S. FDA and the Therapeutic Goods Administration in Australia.

CFDA grants fast-track nod to Engineering Co., Capital Bio devices in under 5 months

Two new medical devices received China FDA marketing approval authorizations in a submission to approval time of just under 5 months, the regulatory agency said, under a process started in March last year.

India drug pricing body ready to crack whip on registration rules

Several of India's largest drug makers are among at least 59 facing possible court action by regulators claiming they failed to register under a new information system of the nation's price-control agency. A few multinationals also are on the list.

U.K. regulators find issues with Indian-owned API distributor Relonchem

U.K. regulators have revoked the license of an Indian-owned API distributor after finding a host of problems at its operations in Cheshire. But the Medicines and Healthcare Regulatory Agency says that Relonchem will be allowed to import some "critical" meds under strict oversight if it is found to be the key supplier.

China plans first-ever rules on animal testing in medical research by year end

Chinese authorities are drafting a national standard expected to be implemented by the end of the year to cover humane treatment of animals used in medical research, including for drug testing. The nation currently has no general rules governing animals in clinical research.

India eases path for small companies to bid in medical product tenders

India's central procurement agency for medicines and other medical products reportedly has lowered some of its standards to allow smaller companies to bid on large contracts for malaria drugs, condoms and other items.

China's SAIC denies probe as reports proliferate on alleged devices crackdown

Three multinational makers of medical devices that together control 80% of China's market for large equipment are said to be under investigation for bribery charges. General Electric, Royal Philips and Siemens reportedly are the targets.

Japan to adopt CDISC clinical data standards from October 2016

Japan's Ministry of Health, Labor and Welfare will require drugmakers to use the Clinical Data Interchange Standards Consortium for submitting clinical trials starting in October 2016, according to a notice issued in Japanese.