FDA Will Narrow Topics For Advisory Committees In Response To HRG Suit
Executive Summary
FDA will ask more directed questions of its advisory committees as a way to narrow the amount of information from NDAs that will be provided to the committees, FDA's Office of Training and Communications Director Nancy Smith, PhD, told the Regulatory Affairs Professionals Society Oct. 5.You may also be interested in...
FDA Aims To Up Transparency By Making Panel Materials Public Sooner
FDA will post advisory committee briefing materials on its Web site at least two business days in advance of meetings, doubling the current lead time in an effort to enhance transparency, according to a 1draft guidance released last week
FDA Aims To Up Transparency By Making Panel Materials Public Sooner
FDA will post advisory committee briefing materials on its Web site at least two business days in advance of meetings, doubling the current lead time in an effort to enhance transparency, according to a 1draft guidance released last week
Public Citizen/FDA Settlement Will Speed Access To Advisory Committee Info
Public access to advisory committee briefing information for non-confidential meetings will be allowed before or on the day of the meeting under a legal settlement between Public Citizen's Health Research Group and FDA. The legal settlement was reached July 6 and takes effect July 16.
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