USA – Lack of product-specific guidance slows ANDAs: FDA study
Researchers at the US Food and Drug Administration (FDA) found that, for drugs that are new chemical entities, generic submissions were more likely when...
USA – Guidance : Nonclinical Testing of Orally Inhaled Nicotine-Containing Drug Products
This guidance provides sponsors with recommendations on the nonclinical information to support development and approval of orally inhaled nicotine-containing drug products, including electronic nicotine...
USA – FDA clarifies reference-listed drugs, other ANDA terms in final guidance
Generic drugmakers have received finalized guidance from the US Food and Drug Administration. In finalizing a 2017 draft, the agency gives sponsors of abbreviated...
USA – FDA postpones DSCA provision enforcement by 3 years
The US Food and Drug Administration (FDA) last week announced it will again delay enforcement of a provision of the Drug Supply Chain Security Act (DSCSA)...
USA – FDA’s COVID-19 vaccine adcomm raises questions as first readouts loom
With several COVID-19 vaccine candidates nearing Phase 3 readouts and the prospect that one or more could receive emergency use authorization (EUA) before the...
USA – FDA plans master protocols to monitor COVID vaccine safety, efficacy
After a vaccine against COVID-19 is authorized or approved, how will its safety and efficacy be assessed? In addition to ongoing postmarket surveillance requirements,...
USA – FDA Approves First Treatment for COVID-19
Today, the U.S. Food and Drug Administration approved the antiviral drug Veklury (remdesivir) for use in adult and pediatric patients 12 years of age and older...
USA – FDA issues clarification on insulin pen distribution
The FDA clarified the intent of November 2019 revisions to labeling for insulin pens that state that health care professionals should dispense the pens to a...
USA – FDA extends pregnancy warning for common pain relievers
Pregnant women should avoid a group of common pain relievers including Advil and Aleve for the last four months of pregnancy, federal health officials...
USA – FDA launches pilots targeting API, finished dosage QMM
Two new pilot programs related to manufacturing quality management have been launched by the US Food and Drug Administration (FDA).
The agency’s Center for Drug...
