USA – FDA finalizes guidance on electronic submission of BA/BE adverse event reports to...
The US Food and Drug Administration (FDA) has finalized guidance that spells out how generic drug manufacturers can electronically submit expedited individual case safety...
USA – FDA Approves New Antibiotic for Three Different Uses
Today, the U.S. Food and Drug Administration approved Zevtera (ceftobiprole medocaril sodium for injection) for the treatment of adults with Staphylococcus aureus bloodstream infections...
USA – FDA shifts IND safety reporting over to FAERS in finalized guidance
The US Food and Drug Administration (FDA) has finalized guidance specifying that after 1 April 2026, sponsors will have to submit investigational new drug...
USA – FDA launches new Quantitative Medicine Center of Excellence
The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) has announced the establishment of a new quantitative medicine (QM)...
USA – FDA reduces number of samples to retain for BA/BE testing
In a part-draft, part-final guidance issued on Tuesday, the US Food and Drug Administration (FDA) finalized its policy on the quantity of reserve samples...
USA – FDA offers guidance on observational studies as RWE
The US Food and Drug Administration (FDA) this week issued new draft guidance on study design and analysis for non-interventional studies being included as...
USA – FDA approves safety labeling changes regarding DPD deficiency for fluorouracil injection products
On March 21, 2024, the Food and Drug Administration approved safety labeling changes for fluorouracil injection products. This effort was a collaboration between FDA’s...
USA – FDA Approves Nonsteroidal Treatment for Duchenne Muscular Dystrophy
Today, the U.S. Food and Drug Administration approved Duvyzat (givinostat) oral medication for the treatment of Duchenne Muscular Dystrophy (DMD) in patients six years...
USA – Industry clamors for clarity on FDA’s advanced manufacturing designation program
Industry is welcoming FDA’s upcoming advanced manufacturing technologies (AMT) program but is clamoring for more clarity on crucial details like what methods will be...
USA – FDA proposes rule for difficult-to-compound drugs, drug categories
The US Food and Drug Administration (FDA) is proposing the creation of two lists of drugs or drug categories that are difficult to compound...
