Update news FDA

The head of the US drugs regulator has cast doubt on President Donald Trump's prediction that a Covid-19 vaccine will be ready this year.


FDA panel backs gene therapy for rare form of blindness

 Spark Therapeutics Inc’s experimental gene therapy for a rare form of blindness improves vision and should be approved, advisers to the Food and Drug Administration concluded on Thursday, 

FDA aims to speed up arrival of complex generic drugs

 The U.S. Food and Drug Administration on Monday announced a series of measures designed to speed to market generic versions of complex drugs such as Mylan NV’s emergency EpiPen

To export products to the US, Vietnamese businesses must understand laws

VietNamNet Bridge - A high number of consignments to the US have been refused this year because Vietnamese exporters were unaware of new regulations set by the US.

Food exporters removed from US list as new regulations take effect

More than 1,000 Vietnamese companies have been removed from the list of companies allowed to export products to the US for failing to extend their registration. 

FDA steps up scrutiny of stem cell therapies

The U.S. Food and Drug Administration is stepping up efforts to better regulate an emerging field of medicine that holds significant promise for curing some of the most troubling diseases by using the body’s own cells.

FDA expands use of AstraZeneca/Merck ovarian cancer drug

 The U.S. Food and Drug Administration on Thursday expanded the use of Lynparza, sold by AstraZeneca Plc and Merck & Co Inc, to include ongoing treatment of patients with recurrent ovarian cancer

Catfish exporters seek other markets as trade barriers to US loom

VietNamNet Bridge - As Vietnam catfish is meeting many barriers in the US market, exporters are considering shifting to Asian markets, especially China.

Vietnamese exports rejected as exporters don’t understand US laws

VietNamNet Bridge - A  number of vegetable and fruit export companies may have their consignments refused as they are unaware of the requirements set by the import country.

Vietnam fruit exports have to meet high standards in foreign markets

VietNamNet Bridge - Vietnam is well known for its tropical fruits, but it has to meet many strict requirements by importing countries in order to export its fruit. 

Roche says FDA fast tracks atezolizumab in specific type of lung cancer

 Roche Holding AG said on Monday the U.S. Food and Drug Administration has granted priority review for atezolizumab for treating people with a specific type of lung cancer.

FDA tightens clinical requirements for transvaginal devices

 The U.S. Food and Drug Administration said on Monday it had taken steps to strengthen the data requirements for surgical mesh devices when used to repair pelvic organ prolapse (POP) via the vagina.

U.S. regulator warns against use of muscle growth product linked to liver injury

The U.S. Food and Drug administration (FDA) on Monday warned consumers to stop using a dietary supplement for muscle growth linked to serious liver damage. 

U.S. FDA approves first device to prevent migraine headaches

The U.S. Food and Drug Administration (FDA) said Tuesday it has approved the marketing of a medical device as a preventative treatment for migraine headaches.

Vietnam’s catfish exports to the US still “safe” this year

It is obvious that the 2014 US Farm Bill will tremendously hurt Vietnamese catfish exports. However, the negative impacts would be made no sooner than early 2015.

U.S. FDA warns against using rice linked to student illnesses

The U.S. Food and Drug Administration on Monday warned food service companies and consumers not to use certain lots of Uncle Ben's infused rice that are linked to "a cluster of illnesses" among students in Texas.

U.S. FDA urges doctors to limit acetaminophen doses

 The U.S. Food and Drug Administration (FDA) on Wednesday urged doctors to discontinue prescribing drugs that contain more than 325 milligrams of acetaminophen per tablet or capsule, to reduce the risk of liver injury.

U.S. drug regulator raises safety concerns on antibacterial soaps

Manufacturers of antibacterial hand soaps and body washes will have to demonstrate that their products are safe for long-term daily use and more effective than plain soap and water in preventing illness and the spread of certain infections,

FDA to ban artificial trans fat in processed foods

 Artificial trans fat, which has been linked to an increased risk of coronary heart disease, will be banned in food supply by the U.S. Food and Drug Administration (FDA).

FDA approves first companion diagnostic test for cancer drug

 The U.S. Food and Drug Administration has approved for the first time a companion diagnostic test for cancer drug Tarceva from Roche to detect certain gene mutations in the most common form of lung cancer known as non-small cell lung cancer.