Drug Approval Standards

FDA says Teresa Michele, in CDER nonprescription drugs program leadership roles since 2013, was being moved to another position in the agency.

In announcement of approving VKT Pharma’s application, FDA included storage and handling instructions common in labeling, suggesting concerns persist about the potential for NDMA to form after products are distributed.

In announcement of approving VKT Pharma’s application, FDA included storage and handling instructions common in labeling, suggesting concerns persist about the potential for NDMA to form after products are distributed.

Approval of numerous Rx formulations hasn’t translated to wider availability when a remedy is needed for anaphylaxis emergency, say FDA and the Margolis Institute in announcing workshop on reducing anaphylaxis-related morbidity and mortality.

OMUFA reauthorization and directions for FDA to provide reports on monograph program and guidance on improving chances for OTC switch applications included in recent stopgap spending bill to end federal government shutdown.

Brazil’s medicines regulator, ANVISA, has hired new staff to help halve the time it takes to register a new medicine in Brazil.

Scientific literature on potential link between prenatal acetaminophen exposure and neurological conditions “now includes FDA’s most recent epidemiological review” completed in May saying research results “insufficient to support a causal association.”

Fresenius has acknowledged that the FDA’s draft guidance could shorten approval timelines and cut trial costs for biosimilars, even though it “may have not fundamentally changed the existing framework.”

Amgen’s CEO Robert Bradway has reaffirmed confidence in the company’s Humira biosimilar, Amjevita, as the company tackles with an ever-growing population of denosumab biosimilars.

The FDA’s proposal to streamline clinical trials is seen as vindication for Teva’s partnership-driven biosimilar play, as the firm targets $400m in added sales by 2027.

With the FDA moving to ease biosimilar approval requirements, Amgen’s leadership urged Washington to preserve the high regulatory bar that has favored experienced biologics manufacturers.

The issues surrounding the FDA's Center for Drug Evaluation and Research director are raising new concerns about more career staff attrition, which likely will negatively impact the drug industry.