2022, Clinical Pharmacology and Licensing

Eplontersen

New Drug Approvals

DECEMBER 24, 2023

December 2022). “Population pharmacokinetic/pharmacodynamic modelling of eplontersen, an antisense oligonucleotide in development for transthyretin amyloidosis” British Journal of Clinical Pharmacology. Viney, Nicholas J.; Schneider, Eugene; Guo, Shuling; Henry, Scott; et al. 88 (12): 5389–5398. doi : 10.1111/bcp.15468.

Clinical Trials

Clinical Trials FDA Clinical Pharmacology FDA Approval

Landiolol

New Drug Approvals

APRIL 19, 2025

21 December 2022. “Pharmacokinetics of landiolol hydrochloride, a new ultra-short-acting beta-blocker, in patients with cardiac arrhythmias” Clinical Pharmacology and Therapeutics. 24 August 2022. Further reading Shiga T (June 2022). . ^ “Details for: Sibboran” Health Canada. Procedure no.:

FDA

FDA Clinical Trials Treatment Trials

Analysis Life Sciences Thank You What We Expect the FDA to do in July and August 2024

Agency IQ

JULY 8, 2024

BY ALEXANDER GAFFNEY, MS, RAC | AUG 31, 2022 6:50 PM CDT | UPDATED JUN 28, 2024 6:45 PM CDT What we expect to be talking about in July and August Chevron Shakeout : Just how soon will it take for companies to begin attacking FDA over the recent Loper Bright Supreme Court case overturning the Chevron Doctrine?

FDA

FDA Science Regulations Production

Analysis Life Sciences Thank You FDA fiscal year in review: New drug approvals in the wake of the pandemic and legislative reforms

Agency IQ

OCTOBER 6, 2023

All products are received in one of two forms: A New Drug Application (or NDA, for pharmaceuticals) or a Biologics License Application (BLA, for biologics). Amanda Conti, AgencyIQ Notably, the increase from FY 2022 was largely driven by biologic products. As a reminder, the U.S. See AgencyIQ’s analysis of these changes here.

FDA

FDA Biosimilars Science Drugs

Analysis Life Sciences Thank You What We Expect the FDA to do in June 2023

Agency IQ

JUNE 2, 2023

In 2022 and 2021, the Spring Unified Agenda was released in early/mid June. The goal: To allow regulatory professionals to better anticipate and prepare for upcoming events and catalysts. The Agenda is typically updated twice per year, and it was last released in early January 2023.

FDA

FDA Science Regulations Production

Analysis Life Sciences Thank You The 51 regulations that FDA is currently working on

Agency IQ

JUNE 16, 2023

The latest Fall 2022 Unified Agenda contains 51 regulations that FDA plans to publish related to human medical product regulation. The latest update, announced this week, is known as the Spring 2023 Unified Agenda. Of those 51, just four are new to the Agenda, having never before been made public.

Regulations

Regulations FDA Science Production

Analysis Life Sciences Thank You What We Expect the FDA to do in November 2023

Agency IQ

OCTOBER 27, 2023

BY ALEXANDER GAFFNEY, MS, RAC | AUG 31, 2022 6:50 PM CDT | UPDATED OCT 25, 2023 10:59 PM CDT Note: At the request of our subscribers, we are beginning to include information about the next two months of expected developments to make it easier for you to keep track of upcoming events. November is packed with regulatory and industry meetings.

FDA

FDA Science Regulations Production

Analysis Life Sciences Thank You What We Expect the FDA to do in May and June 2024

Agency IQ

MAY 3, 2024

What We Expect the FDA to do in May and June 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. The following PDUFA dates were obtained from publicly available sources.

FDA

FDA Science Regulations Clinical Trials

Analysis Life Sciences Thank You 166 guidance documents the FDA is actively working on in 2024 (and beyond)

Agency IQ

FEBRUARY 15, 2024

Draft published December 2022. Priority B List. CDRH Final 12/29/2023; overdue FDA must issue final guidance no later than one year after the close of the public comment period for the draft guidance.

FDA

FDA Science Biosimilars Clinical Trials

Analysis Life Sciences Thank You What We Expect the FDA to do in October 2023

Agency IQ

SEPTEMBER 29, 2023

BY ALEXANDER GAFFNEY, MS, RAC | AUG 31, 2022 6:50 PM CDT | UPDATED SEP 25, 2023 10:39 PM CDT Note: At the request of our subscribers, we are beginning to include information about the next two months of expected developments to make it easier for you to keep track of upcoming events.

FDA

FDA Science Regulations Production

Analysis Life Sciences Thank You What We Expect the FDA to do in December 2023

Agency IQ

DECEMBER 1, 2023

BY ALEXANDER GAFFNEY, MS, RAC | AUG 31, 2022 6:50 PM CDT | UPDATED NOV 27, 2023 10:59 PM CST Note: At the request of our subscribers, we are beginning to include information about the next two months of expected developments to make it easier for you to keep track of upcoming events.

FDA

FDA Science Regulations Production

Analysis Life Sciences Thank You What We Expect the FDA to do in March and April 2024

Agency IQ

MARCH 1, 2024

FDA March 13 BLA Regulation FDA’s Biologics License Applications and Master Files rule becomes effective FDA March 25 Quality Management Maturity Deadline to participate in the Quality Management Maturity Prototype Assessment Protocol Evaluation Program. The following PDUFA dates were obtained from publicly available sources.

FDA

FDA Science Clinical Trials Regulations

Analysis Life Sciences Thank You What We Expect the FDA to do in February and March 2024 (Updated)

Agency IQ

FEBRUARY 2, 2024

What We Expect the FDA to do in February and March 2024 (Updated) In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. The following PDUFA dates were obtained from publicly available sources.

FDA

FDA Science Clinical Trials Regulations

Acoramidis

New Drug Approvals

APRIL 21, 2025

“First-in-Human Study of AG10, a Novel, Oral, Specific, Selective, and Potent Transthyretin Stabilizer for the Treatment of Transthyretin Amyloidosis: A Phase 1 Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study in Healthy Adult Volunteers” Clinical Pharmacology in Drug Development. March 2022).

FDA Approval

FDA Approval FDA Production Treatment

Analysis Life Sciences Thank You The 53 regulations that FDA is currently working on

Agency IQ

JULY 12, 2024

Proposed Rule Pediatric Study Plan Requirements for New Drug and Biologics License Applications October 2024 FDA is proposing to amend its existing regulations and add new regulations pertaining to submission of required initial pediatric study plans (iPSPs) under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Regulations

Regulations FDA Science Production

Drug Discovery Digest

Eplontersen

Landiolol

Trending Sources

Analysis Life Sciences Thank You What We Expect the FDA to do in July and August 2024

Analysis Life Sciences Thank You FDA fiscal year in review: New drug approvals in the wake of the pandemic and legislative reforms

Analysis Life Sciences Thank You What We Expect the FDA to do in June 2023

Analysis Life Sciences Thank You The 51 regulations that FDA is currently working on

Analysis Life Sciences Thank You What We Expect the FDA to do in November 2023

Analysis Life Sciences Thank You What We Expect the FDA to do in May and June 2024

Analysis Life Sciences Thank You 166 guidance documents the FDA is actively working on in 2024 (and beyond)

Analysis Life Sciences Thank You What We Expect the FDA to do in October 2023

Analysis Life Sciences Thank You What We Expect the FDA to do in December 2023

Analysis Life Sciences Thank You What We Expect the FDA to do in March and April 2024

Analysis Life Sciences Thank You What We Expect the FDA to do in February and March 2024 (Updated)

Acoramidis

Analysis Life Sciences Thank You The 53 regulations that FDA is currently working on

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