News

Latest News | 20 March 2013

Advisory Committee to Assess How FDA Communicates Adverse Events to Public

1 Likes

US regulators plan to hold a meeting in the coming weeks to address how it communicates risk about regulated products, including how best to communicate adverse event information it receives from its Read More...

---

Latest News | 25 February 2013

Takeda, Affymax Recall All Lots of Anemia Drug as Advisory Committee Remarks Prove Prophetic

0 Likes

Pharmaceutical companies Affymax and Takeda have announced a recall of all lots of their Omontys drug after becoming aware of more than a dozen cases of anaphylaxis, of which three were fatal to Read More...

---

Latest News | 6 February 2013

FDA Calls on Public to Fill Dozens of Open Device-Related Advisory Committee Seats

0 Likes

The US Food and Drug Administration (FDA) is calling for the nomination of new voting members to serve on several of its medical device-related public advisory committees, saying it will accept Read More...

---

Latest News | 29 January 2013

Does Advisory Committee Transparency Lead to Better Regulatory Decision Making?

0 Likes

The US Food and Drug Administration (FDA) often courts controversy with its decisions to approve or deny new therapies. In the wake of some high-profile scandals in the past decade, the agency has Read More...

---

Latest News | 3 December 2012

FDA Seeks Industry Representative for Device Advisory Committee

0 Likes

For the second time in as many months, the US Food and Drug Administration (FDA) is calling on the public—and members of the medical device industry, in particular—to nominate new members to one of Read More...

---

Latest News | 12 November 2012

Consumer Advocacy Group Fires Back at FDA Over Transparency of Advisory Committees

0 Likes

The consumer advocacy group Project on Government Oversight (POGO) is re-engaging the US Food and Drug Administration (FDA) on whether a panel of experts convened by the agency to review the safety of Read More...

---

Latest News | 11 October 2012

FDA Advisory Committee to Assess 'Warning Fatigue'

0 Likes

An advisory committee meeting convened on behalf of the US Food and Drug Administration (FDA) is set to discuss factors influencing the communication concerning regulated healthcare products, Read More...

---

Latest News | 21 September 2012

DHHS Plans to Assess Need for Revisions to Human Research Protections at Upcoming Meeting

0 Likes

The US Department of Health and Human Services (DHHS) is planning to meet in October to discuss whether current protections afforded to human research subjects are adequate, or whether new regulations Read More...

---

Latest News | 10 September 2012

FDA Science Board Seeks New Members

0 Likes

US regulators are calling for new nominees to serve on the US Food and Drug Administration's (FDA) Science Board—an advisory committee charged with providing advice to the agency regarding science and Read More...

---

Latest News | 6 September 2012

Human Protections Oversight Body Seeks New Members

0 Likes

Officials at the US Department of Health and Human Services (DHHS) are looking for two new members to serve on the Secretary's Advisory Committee on Human Research Protections (SACHRP), the agency Read More...

---