Alta Sciences

FEBRUARY 8, 2024

Utilizing 10 state-of-the-art simulators available in-house at our Montréal clinical facility (with the capacity for more than 20), we are equipped to measure a range of studies; from impairment in cognition and comparing compounds to assessing the impact on new formulations have on impairment.

Clinical Trials 52

Clinical Trials Trials Clinical Pharmacology Clinical Development 52

Agency IQ

SEPTEMBER 15, 2023

Until recently, the FDA relied on a monograph process through which firms could bring OTC drugs to market without FDA approval 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.

Science 40

Science FDA Clinical Trials Clinical Pharmacology 40

The Premier Consulting Blog

SEPTEMBER 11, 2024

The 505(b)(2) new drug application (NDA) pathway offers a unique opportunity for small molecule developers to bring innovative products to market more efficiently by leveraging existing data they do not own or have right of reference to.

Drugs 52

Drugs Packaging Clinical Pharmacology Small Molecule 52

Agency IQ

OCTOBER 6, 2023

Amanda Conti, AgencyIQ What kind of biologic products entered the market? Under the 351(k) pathway, biosimilar product developers are expected to conduct foundational analytical studies, animal studies, clinical pharmacology and immunogenicity assessments, and additional clinical evaluations to demonstrate biosimilarity or interchangeability.

FDA 52

FDA Biosimilars Science Production 52

Agency IQ

SEPTEMBER 29, 2023

AgencyIQ October 1 Nitrosamine testing due to FDA. Due to the presence of nitrosamines in certain drug products, FDA had required that drug manufacturers conduct an initial risk assessment of approved or marketed products, with an initial completion date of October 1, 2021, and then confirmatory testing due by October 1, 2023.

FDA 40

FDA Science Regulations Production 40

Agency IQ

JUNE 16, 2023

0910-AI26 September 2023 March 2023 Final Rule Stage Biologics License Applications and Master Files The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) deemed any biological product approved in a new drug application (NDA) to be a biologics license application (BLA) on March 23, 2020.

Regulations 40

Regulations FDA Science Production 40

The Pharma Data

FEBRUARY 8, 2021

Food and Drug Administration (FDA) approval for nmCRPC on February 14, 2018 and was approved for mCSPC on September 17, 2019. In post marketing experience, QT prolongation, and torsades de pointes have been observed in patients who develop hypokalemia while taking ZYTIGA ®. 2 ERLEADA ® received U.S.

Pharmaceutical Companies 52

Pharmaceutical Companies Treatment Clinical Trials Therapies 52