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FDA

Latest Headlines

Latest Headlines

FDA bars Basilea antibiotic from U.S. market, demands new PhIII data

Close to a year ago Switzerland's Basilea raised a red flag about its U.S. strategy for its antibiotic ceftobiprole, noting that the FDA's new standard requiring two late-stage studies for a program like this could present a major hurdle. Today company execs confirmed that the regulatory path into the U.S. is closed for now.

A new excuse for pharma to avoid the Twitterverse, thanks to the FDA

Any brand managers eager to jump into Twitter as soon as the FDA gave the go-ahead? No such luck. Last week's social media guidance on risk disclosures may have cleared up some of the regulatory fog, but in this case, clarity isn't a positive.

FDA's social media translation for brand managers: Don't use Twitter

Any brand managers eager to jump into Twitter as soon as the FDA gave the go-ahead? No such luck. Last week's social media guidance on risk disclosures may have cleared up some of the regulatory fog, but in this case, clarity isn't a positive.

FDA issues guidances on development of nanotechnology products

The FDA on June 24 issued three final guidances and a draft guidance for industry to clarify the use of nanotechnology in FDA-regulated products, a decision that will affect the drug delivery arena as it becomes more dependent on nano-engineerin g.

Qiagen wins FDA OK for organ transplant test

Qiagen received FDA approval on June 24 under a full PMA for an assay that monitors the viral load of cytomegalovirus (CMV), a common virus that can be fatal to weakened immune systems, in organ transplant patients.

FDA finds contamination issues at GSK vax plant

The FDA has sent a scathing warning letter to GlaxoSmithKline's influenza vaccine plant in Quebec City, Canada, saying it is not doing near enough to avoid contamination of products there. It said GSK has had ongoing problems with bacteria at the facility and had to reject a fifth of its production just this year.

FDA addresses gender data disparity in device trials

The Center for Devices and Radiological Health, an affiliated FDA center, is proactively working to reduce the gender information gap plauging some clinical trials.

In test of FDA guidelines, medical mobile app Abriiz escapes scrutiny

The Food and Drug Administration opted to use its enforcement discretion by not regulating mobile health app Abriiz from Ideomed. This case provides an early glimpse at how the agency will enforce its mobile medical app guidelines that were finalized just last fall.

FDA moves for more warnings on testosterone products

The FDA has dealt a blow to the $1.6 billion testosterone supplement market, which includes the top-selling AndroGel, made by AbbVie. The drug labels must now include a general warning about the risk of blood clots in veins.

FDA's long-awaited Twitter guidance gives biopharma certainty and constraints

The FDA continued to build its patchwork quilt of social media guidance this week with the publication of two new draft documents, one of which is the long-awaited discussion on how to use Twitter. And while the guidance places significant constraints on how biopharma can use the platform, some think the clarity it brings will prompt companies to become more active tweeters.