The Small Biz Buzz
The Information Source for Regulated Domestic and International Small Pharmaceutical Business
The Information Source for Regulated Domestic and International Small Pharmaceutical Business
The
Food and Drug Administration (FDA) is announcing the availability of a
guidance for industry entitled ``Oversight of Clinical Investigations--A
Risk-Based Approach to Monitoring.'' This guidance assists sponsors in
developing risk-based monitoring strategies and plans for clinical
investigations of human drugs, biologics, medical devices, and
combinations thereof. The overarching goal of this guidance is to
enhance human subject protection and the quality of clinical trial data
by focusing sponsor oversight on the most important aspects of study
conduct and reporting. The guidance makes clear that sponsors can use a
variety of approaches to meet their responsibilities for monitoring
investigational new drug or investigational device exemption studies.
The
Food and Drug Administration (FDA) is announcing an initiative in the
Center for Drug Evaluation and Research (CDER) involving the review of
draft guidance documents issued before 2010 to determine their status,
and to decide whether those guidances should be withdrawn, revised, or
finalized with only minor changes. Guidances that are no longer up to
date, and for which more current information is available, will be
withdrawn. Guidances that reflect CDER's current thinking, CDER will
decide whether to revise or finalize. This notice describes CDER's
initiative, announces the first group of guidances to be withdrawn,
describes in general terms draft guidances under consideration for
revision or finalization, and explains how CDER is making this process
as transparent as possible.
The
Food and Drug Administration's (FDA) Center for Drug Evaluation and
Research, in cosponsorship with the American College of
Gastroenterology, the American Gastroenterological Association, the
Crohn's and Colitis Foundation of America, Inc., the North American
Society for Pediatric Gastroenterology, Hepatology, and Nutrition, and
the Pediatric IBD Foundation, is announcing a 2-day public workshop
entitled ``Gastroenterology Regulatory Endpoints and the Advancement of
Therapeutics (GREAT II).''
The
Food and Drug Administration (FDA or the Agency) is announcing the
start of the Secure Supply Chain Pilot Program (SSCPP). The SSCPP is
intended to assist FDA in its efforts to prevent the importation of
adulterated, misbranded, or unapproved drugs by allowing the Agency to
focus its resources on imported drugs that fall outside the program and
may pose risks. Such a program would increase the likelihood of
expedited entry for specific finished drug products and active
pharmaceutical ingredients (APIs) imported into the United States that
meet the criteria for selection under the program. This notice outlines
the eligibility requirements and the process for applying for
participation in the SSCPP.
The
Food and Drug Administration's (FDA) Office of Orphan Products
Development is announcing the following meeting entitled ``The Food and
Drug Administration/European Medicines Agency Orphan Product Designation
and Grant Workshop.'' This 1-day workshop is intended to provide
valuable information about the FDA and European Medicines Agency (EMA)
Orphan Drug Designation programs, the FDA Humanitarian Use Device (HUD)
Designation program, and the FDA Orphan Products Grant program to
participants representing pharmaceutical, biotechnology, and device
companies, as well as academics.
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