Drug Discovery World

AUGUST 15, 2023

However, development pipelines across multiple therapeutic areas are still not meeting the anticipated clinical outcomes that are needed for bringing new and cost-effective drugs to patients. 2012) Nature Reviews Drug Discovery, 11: 191–200. Journal of Cardiovascular Pharmacology, 20: S96-105 Aktas et al. Scannell & Bosley.

Drugs 130

Drugs Clinical Pharmacology Disease Engineering 130

Agency IQ

SEPTEMBER 29, 2023

Start Date End Date Event Event Type Center 09/27/2023 09/28/2023 13th Annual Global Summit on Regulatory Science Summit National Center for Toxicological Research 09/27/2023 09/27/2023 Cellular, Tissue, and Gene Therapies Advisory Committee Advisory Committee Meeting CBER 09/28/2023 09/28/2023 Electronic Drug Registration and Listing (eDRLS) Using (..)

FDA 40

FDA Science Regulations Production 40

The Pharma Data

FEBRUARY 8, 2021

Hypokalemia, Fluid Retention, and Cardiovascular Adverse Reactions due to Mineralocorticoid Excess – ZYTIGA ® may cause hypertension, hypokalemia, and fluid retention as a consequence of increased mineralocorticoid levels resulting from CYP17 inhibition [see Clinical Pharmacology (12.1)]. Accessed February 2021.

Pharmaceutical Companies 52

Pharmaceutical Companies Treatment Clinical Trials Trials 52

Agency IQ

JUNE 16, 2023

By harmonizing with the International Electrotechnical Commission, this rule will decrease the regulatory burden on industry and allow the Agency to take advantage of the expertise of the international committees, thereby also saving resources.

Regulations 40

Regulations FDA Science Production 40

Agency IQ

OCTOBER 27, 2023

Title Type Comments Close Fixed-Combinations and Single-Entity Versions of Previously Approved Antiretrovirals for the Treatment or Prevention of Human Immunodeficiency Virus-One Under the President’s Emergency Plan for Acquired Immunodeficiency Syndrome Relief Guidance November 1 Post-Warning Letter Meetings Under GDUFA Guidance November 6 In-Home (..)

FDA 40

FDA Science Regulations Production 40

Agency IQ

DECEMBER 1, 2023

Title Type Comments Close Optimizing the Use of Postapproval Pregnancy Safety Studies; Public Workshop RFI November 30 Medical Devices; Laboratory Developed Tests Rule December 4 Stimulant Use Disorders: Developing Drugs for Treatment Guidance December 4 Modernizing the Food and Drug Administration’s Premarket Notification Program Notice December (..)

FDA 40

FDA Science Regulations Production 40