March 7, 2024
UPDATE: On March 20, 2023, the FDA announced the withdrawal (revocation) of the biologics license for BLENREP indicated for the treatment of adult patients with relapsed or […]
March 7, 2024
The prevailing view of menopause as an endocrine deficiency has led to a “disease-based model” that leads to over-medicalisation of this inevitable life transition, according to […]
March 7, 2024
WEST PALM BEACH, Fla. — Patient-reported outcomes (PROs) define the issues that matter to the patient, but their potential in multiple sclerosis (MS) is likely to […]
March 7, 2024
TOPLINE: The odds of having cognitive impairment may be increased among children with atopic dermatitis (AD), primarily among those with neurodevelopmental disorders, such as attention-deficit/hyperactivity disorder […]
March 7, 2024
Criteria to Participate in the Emerging Technology Program To qualify for participation in the Emerging Technology Program, technologies need to: Have the potential to improve product […]
March 7, 2024
A Danish study showing that about half of patients with newly diagnosed inflammatory bowel disease (IBD) had findings consistent with spondyloarthritis (SpA) was highlighted as one […]
March 7, 2024
Benefits to participating in the Emerging Technology Program. Participants in the program can expect: Pre-submission face-to-face interactions with ETT members and review staff to answer technical […]
March 7, 2024
The Emerging Technology Program serves as an entry point for new technologies that will potentially be included in a regulatory filing for a specific drug product. […]
March 7, 2024
FDA recognizes that adopting innovative approaches to manufacturing may present both technical and regulatory challenges. Pharmaceutical companies may have concerns that developing such technologies could result […]
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