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Pharmaceutical firms developing treatments for chronic acne should design clinical studies with co-primary endpoints that evaluate both acne lesion counts and an investigator’s global assessment (IGA) scale of overall acne severity, according to a new FDA draft guidance.
The FDA has released draft guidance on how to comply with the 2003 Pediatric Research Equity Act, which requires new drug applications and biologics license applications to contain a pediatric assessment unless a waiver or deferral has been approved by the FDA.
The FDA released draft guidance late last week on how to comply with the Pediatric Research Equity Act, which was signed into law Dec. 3, 2003, and requires new drug applications (NDAs) and biologics licensing applications (BLAs) to contain a pediatric assessment unless a waiver or deferral has been approved by the FDA.
The FDA's final rule defining the primary mode of action (PMOA) of combination products will give firms a better understanding of how the agency determines which FDA office will assume regulatory oversight of their products, says an FDA official.
While progress on the follow-on biologics front has been slow in the U.S., the European Union (EU) continues to forge ahead toward an approval pathway.
The FDA generally will not require long-term follow-up observations of participants in clinical trials of gene transfer technology when the risk of delayed adverse events is low, according to a draft guidance.