Drug Target Review

FEBRUARY 28, 2024

Chem Immunol Allergy 86:151-183 (2005). Normality sensing licenses local T cells for innate-like tissue surveillance. Regulation of cutaneous malignancy by gammadelta T cells. Human γδ TCR repertoires in health and disease. Cells 9(40):800 (2020). Holtmeier W, Kabelitz D. Kalyan S, Kabelitz D. Cell Mol Immunol 10(1):21-9 (2013).

Therapies 105

Therapies Engineering Molecular Biology Science 105

The Premier Consulting Blog

NOVEMBER 16, 2022

Although novel excipients can be a part of any new drug application (NDA) or biologics license application (BLA) development program, they seem to be more common with the 505(b)(2) pathway, since many companies use cutting-edge delivery technologies to solve issues associated with previously approved drugs.

FDA 52

FDA Packaging Production Licensing 52

Agency IQ

JANUARY 26, 2024

Though regulations guide some aspects of how expiration dates are determined, the agency has but limited power to extend those dates unilaterally. As part of current good manufacturing practice (cGMP) regulations, drugs are required to bear an expiration date determined by “appropriate stability testing,” according to 21 CFR 211.137.

Science 40

Science FDA Production Packaging 40

Agency IQ

JUNE 16, 2023

Highlights of the EPA’s Unified Agenda for Spring 2023 The Office of Management and Budget has released the Unified Agenda for Spring 2023, which outlines the regulations that agencies expect to release in 2023 and 2024. This information would be used in considering the regulation of asbestos.

Regulations 40

Regulations Compliance Production Science 40

The Pharma Data

NOVEMBER 9, 2020

Amgen develops product candidates internally and through licensing collaborations, partnerships and joint ventures. Furthermore, Amgen’s research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. 2005; 172; 149–60. 7 Wenzel S.

Trials 52

Trials Production Clinical Trials Government 52

The Pharma Data

DECEMBER 21, 2020

Amgen develops product candidates internally and through licensing collaborations, partnerships and joint ventures. Furthermore, Amgen’s research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. 2005; 172: 149-160.

Trials 40

Trials Production Clinical Trials Therapies 40

Codon

AUGUST 10, 2023

Credit: Bruce Wetzel and Harry Schaefer, NCI, NIH | License Progress in biology is arguably moving faster today than at any point in the course of human history. Nature (2005). Link Gene Expression & Regulation →Genetic regulatory mechanisms in the synthesis of proteins , by Jacob F. & & Collins J.J.

DNA 92

DNA Cell Biology Molecular Biology Engineering 92