FDA authorizes use of Ebola test
The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to authorize use of the LightMix® Ebola Zaire rRT-PCR Test…
News
FDA approves Gardasil 9 for prevention of cancers caused by additional types of HPV
On Dec. 10, the U.S. Food and Drug Administration (FDA) approved Gardasil 9 (Human Papillomavirus 9-valent Vaccine, Recombinant) for the prevention of certain diseases…
Ebola updates from FDA
The U.S. Food and Drug Administration (FDA) is working to help expedite the development and availability of medical product, such as treatments, vaccines, diagnostic…
FDA warns against laparoscopic power morcellators for hysterectomy or myomectomy
On Nov. 24, the U.S. Food and Drug Administration (FDA) warned against using laparoscopic power morcellators for hysterectomy or myomectomy in the vast majority…
FDA approves vaccine for meningococcal disease
On Oct. 29, the U.S. Food and Drug Administration (FDA) approved Trumenba, the first vaccine licensed in the United States to prevent invasive meningococcal…
FDA approves new labeling for Embeda ER capsules
On Oct. 17, the U.S. Food and Drug Administration (FDA) approved new labeling for Embeda (morphine sulfate and naltrexone hydrochloride) extended-release (ER) capsules, an…
FDA approves two drugs for idiopathic pulmonary fibrosis
On Oct. 15, the U.S. Food and Drug Administration (FDA) approved Ofev (nintedanib) http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm418994.htm and Esbriet (pirfenidone) for the treatment of idiopathic pulmonary fibrosis.…
FDA issues recommendations for strengthening cybersecurity of devices
On Oct. 1, the U.S. Food and Drug Administration (FDA) finalized recommendations to manufacturers for managing cybersecurity risks to better protect patient health and…
FDA authorizes use of Ebola test
The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to authorize use of the LightMix® Ebola Zaire…
FDA approves Gardasil 9 for prevention of cancers caused by additional types of HPV
On Dec. 10, the U.S. Food and Drug Administration (FDA) approved Gardasil 9 (Human Papillomavirus 9-valent Vaccine, Recombinant) for the prevention of…
Ebola updates from FDA
The U.S. Food and Drug Administration (FDA) is working to help expedite the development and availability of medical product, such as treatments,…
FDA warns against laparoscopic power morcellators for hysterectomy or myomectomy
On Nov. 24, the U.S. Food and Drug Administration (FDA) warned against using laparoscopic power morcellators for hysterectomy or myomectomy in the…
FDA approves vaccine for meningococcal disease
On Oct. 29, the U.S. Food and Drug Administration (FDA) approved Trumenba, the first vaccine licensed in the United States to prevent…
FDA approves new labeling for Embeda ER capsules
On Oct. 17, the U.S. Food and Drug Administration (FDA) approved new labeling for Embeda (morphine sulfate and naltrexone hydrochloride) extended-release (ER)…
FDA approves two drugs for idiopathic pulmonary fibrosis
On Oct. 15, the U.S. Food and Drug Administration (FDA) approved Ofev (nintedanib) http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm418994.htm and Esbriet (pirfenidone) for the treatment of idiopathic…
FDA issues recommendations for strengthening cybersecurity of devices
On Oct. 1, the U.S. Food and Drug Administration (FDA) finalized recommendations to manufacturers for managing cybersecurity risks to better protect patient…
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