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At the same time, looking to 2018 when there were 29 meetings to consider new drugs, the number appears to be falling each year, with only 6 that occurred during the first half of 2021. Fewer meetings – more approvals. That said, BT would be a lagging indicator since it can be granted so early in the development process.
. “Population pharmacokinetic/pharmacodynamic modelling of eplontersen, an antisense oligonucleotide in development for transthyretin amyloidosis” British Journal of ClinicalPharmacology. S2CID 250989659. ^ “Eplontersen: FDA-Approved Drugs” U.S. Food and Drug Administration (FDA).
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Metabolism of de novo-designed macrocyclic drugs approved by the FDA By Julia Shanu-Wilson To date, only 4% (67) of FDAapproved drugs are macrocycles [1]. Current macrocycles in clinical use generally focus on treatment of infectious diseases, cancer and auto-immune disorders. Gangl et al.,
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Until recently, the FDA relied on a monograph process through which firms could bring OTC drugs to market without FDAapproval so long as it adhered to pre-set terms under the monograph. FDA’s cough cold monograph only designates two oral products as GRASE – phenylephrine and pseudoephedrine.
Biosimilar product developers are expected to conduct foundational analytical studies, animal studies, clinicalpharmacology and immunogenicity assessments, and additional clinical evaluations to demonstrate biosimilarity or interchangeability. That guidance document was updated in September 2021 to include 25 questions.
[i] Results will be featured in an oral presentation at the American Society of Clinical Oncology’s Genitourinary (ASCO GU) Cancers Symposium, taking place virtually February 11-13, 2021 (Abstract #9; Oral Abstract Session: Prostate Cancer, February 11, 12:45 PM-2:00 PM EST). Accessed February 2021. Accessed February 2021. [iv]
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