Topic:

Regulatory

Latest Headlines

Latest Headlines

Vietnam-made vaccines WHO-cleared for export

Vietnam has become the 39th nation cleared for global exports of the vaccines it makes, joining an increasingly crowded field of local champions to multinational heavyweights. The World Health Organization gave that clearance recently for a country that expects to be a leading producer within the next 20 to 30 years.

Counterfeit Botox again found in the U.S.

More counterfeit Botox has made its way into the U.S. and, the FDA thinks, into physician offices. The agency is warning providers that they need to make sure they don't have any of it because it is believed to be unsafe.

FDA issues new guidelines on acceptance of data from overseas clinical trials

The FDA issued guidelines on its acceptance of medical device clinical data from overseas studies in a just-issued draft guidance, saying the "increasing globalization of clinical trials presents challenges to both US and foreign regulators."

FDA, industry scrambling to clarify or design new regs covering lab-developed tests

Science is rapidly shaping the landscape of the diagnostics industry, from the research into genetics and new materials like graphene, to the regulatory science practiced at the FDA.

WuXi PharmaTech subsidiary gears up DNAnexus partnership to offer cloud genomics worldwide

Shanghai-based WuXi PharmaTech said its subsidiary WuXi NextCODE Genomics has joined with U.S.-based DNAnexus to offer a wider range of genomics services worldwide, including cloud-based services, according to a press release on Wednesday.

Drumbeat grows for better access to medicines, hospital reforms in China

A leading Chinese health official renewed a call for greater access to medicines and other treatments through a more competitive distribution system and reforms in the way hospitals operate.

Japan faces surge in healthcare costs as assessment system challenges loom

Japan can expect the cost of its medical care to increase by more than $33 billion over the next five years, a group of the nation's legislators said, calling it a threat to the government's budget-deficit plans.

India eyes bringing all drugs under NPPA price control system

A committee of India's parliament voted to bring all drugs sold in the country under price controls determined by the National Pharmaceutical Pricing. The NPPA's reach currently is limited to 509 drugs on the nation's list of essential drugs.

India seeks to step up oversight of drugs and devices starting with new department name

India's Department of Pharmaceuticals could soon get a new name to reflect all of its authority: Department of Pharmaceuticals and Medical Devices. The department is a unit of the Ministry of Chemicals and Fertilisers.

Chinese API maker cited with second FDA warning letter

The FDA may be having difficulty getting inspectors stationed in China, but that has not stopped it from issuing warning letters to drug and ingredient makers there who have issues. The agency posted a second warning letter today for API maker Yunnan Hande Bio-Tech, which was previously cited in 2010.