Category archives for: FDA News

FDA Teams with to Better Serve Consumers

The Food and Drug Administration’s Office of Communications has concluded a Memorandum of Understanding with, which has agreed, a.o., to post FDA Consumer Updates and other content on its website, produce a newsletter and alerts that feature FDA content, and provide direct links back to FDA web content such as the agency’s RSS feed […]

'Superbug' Scope Maker Had Altered Design to Make Cleaning Easier Even Before Outbreaks

The endoscopes allegedly responsible for a wave of "superbug" outbreaks had been redesigned in recent years in the hopes of making them easier to clean and less likely to spread bacteria from patient to patient, ABC News has learned, but the modifications might have created different challenges as the scopes continue to transmit antibiotic-resistant bugs. […]

Federal Justice Department part of raid

The Canadian Justice Department confirms it is the lead agency in an RCMP raid on the Winnipeg headquarters of on Wednesday. RCMP officers were at the offices on Terracon Place on Wednesday, but a police spokesperson wouldn’t say why, citing officer safety. Record sealing, also known as a confidentiality order, is the process of removing the […]

FDA approves Emergent BioSolutions' inhaled anthrax treatment

Emergent BioSolutions Inc said the U.S. Food and Drug Administration approved its treatment for inhaled anthrax, triggering a $ 7 million milestone payment from the Department of Health and Human Services (HHS). The company developed the treatment, Anthrasil, as part of a $ 160 million contract it signed in 2005 with the Biomedical Advanced Research […]

FDA issues mobile app to search for drug shortages

By Reuters Staff The U.S. Food and Drug Administration this week issued a mobile app specifically for searching for information about drug shortages. App users can identify current drug shortages, resolved shortages, and drug discontinuations. Drug shortages can delay or deny patient care and known shortages may lead doctors to rely on alternatives that may […]

Biosimilars: More Treatment Options Are on the Way

The Food and Drug Administration (FDA) is approving Zarxio (filgrastim-sndz), the first biosimilar product (or biosimilar), and expects to approve others in the months ahead. What are biosimilars? How will they affect patient treatment? FDA Consumer Health Information Updates

U.S. FDA updates safety alert for 'superbug' scopes

U.S. health regulators issued an updated safety alert on Wednesday for endoscopes linked to drug-resistant "superbug" bacteria in California hospitals. The Food and Drug Administration said it was not recommending that healthcare providers cancel procedures performed with a duodenoscope for patients who need them. It did recommend that healthcare providers inform patients of the risks, […]

Scopes That Spread UCLA 'Superbug' Were Awaiting FDA Clearance

The manufacturer of the scopes that spread a drug-resistant "superbug" to seven California patients had tweaked the scopes' design and was selling them without federal permission to do so, according to the Food and Drug Administration. Seven people have become infected with the drug-resistant "superbug" known as CRE at Ronald Reagan UCLA Medical Center after […]

FDA Says It Knew Scopes That Allegedly Spread 'Superbug' Could Transmit Bacterial Infections

The revelation that contaminated endoscopes were cleaned according to manufacturer instructions but still allegedly caused seven people to become infected with a deadly drug-resistant bacteria has raised questions about whether the scopes are too difficult to clean. Seven people have become infected with the drug-resistant "superbug" known as CRE at Ronald Reagan UCLA Medical Center […]

Milk-Allergic? There May Be Milk in That Dark Chocolate

If you or someone in your household is allergic to milk, take heed: a recent study by FDA found that many of the dark chocolate products contain milk. And you can’t always tell that’s the case simply by reading the food label. FDA Consumer Health Information Updates

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