Topic:

Regulatory

Latest Headlines

Latest Headlines

Silk Road scores FDA approval for less invasive stent system

Silk Road Medical snagged FDA premarketing approval for its innovative transcarotid stent system, a big win for the company as it scores key regulatory signoffs for the device and forges ahead with product development.

FDA proposes new rules for animal drug compounding

On May 17, the FDA announced that it released a draft guidance that sets out rules for compounding animal drugs from bulk substances. In so doing, the FDA is recognizing that in some situations, treating animals with specially formulated versions of approved drugs would be impossible.

NEA startup ClarVista gets $14.5M to gain CE mark for intraocular lens

Startup ClarVista Medical expects to use a newly gleaned $14.5 million financing to get a CE mark for its Harmoni modular intraocular lens system. The design of the cataract IOL is intended to make it easier for surgeons to correctly position the lens, as well as to make it simpler to exchange the optical component when required because of a dual-component structure.

Bluebird beats a path to early approval for its pioneering gene therapy

Bluebird bio, developing a potential cure for a rare blood disorder, is angling for an accelerated approval as it works through clinical trials, setting out a regulatory framework that could get the gene therapy on the market sooner than expected.

Taiwan recalls batches of injectable sodium chloride made by Y.F. Chemical

Taiwanese authorities issued a nationwide advisory to hospitals to avoid certain batches of injectable sodium chloride made by Y.F. Chemical, a move that followed a spate of over-the-counter drug recalls in April.

India drug IP laws in spotlight again in local Fresenius Kabi-Pfizer case

India's policy regarding intellectual property protection has bounced back once again to deny an MNC patent challenged by a local drugmaker. This one was filed by the local unit of Fresenius Kabi Oncology against a Pfizer patent.

Wockhardt faces long haul on FDA travails, Business Today says

India's Wockhardt faces a tough road to travel to revive its fortunes after a spate of trouble with the U.S. FDA since 2013 that saw the closure of two plants and recent product recalls bedevil the company, India's Business Today magazine reports.

Thailand faces pushback from private hospitals on cost claims

Thailand's efforts to rein in the cost of drugs and medical treatment face a pushback by the country's private hospitals. The head of the Private Hospitals Association, Chalerm Hanpanich, said public hospitals do not bear the infrastructure costs.

FDA approves pediatric version of Treximet to treat migraines

The FDA approved its first combination therapy to treat migraines in pediatric patients, giving its blessings to Pernix Therapeutics' Treximet for use in patients ages 12 to 17.

FDA blesses Baxter saline plant in Spain to produce for U.S.

A Baxter International plant in Spain which has been drafted to help alleviate a shortage of saline in the U.S. has gotten a new FDA designation that gives it more flexibility.