Drug Development, Licensing and Webinar

6 Operational Considerations You Need To Know for Psychedelic Trials

Conversations in Drug Development Trends

OCTOBER 26, 2022

Having worked in psychedelic research since the advent of industry-sponsored trials, Worldwide Clinical Trials has amassed the expertise needed to execute these studies successfully, recently sharing insights in a webinar titled “ Demystifying Complex Operations in Psychedelic Research ,” available on-demand now. Check out the full webinar !

Trials

Trials Clinical Trials Licensing Licensing

Unlocking Innovation: A Composable Commerce Approach to Headless with SAP Commerce

Perficient: Drug Development

OCTOBER 27, 2023

The webinar covered three pivotal aspects: Seamless Migration, Future-Ready Strategies, and the PWA Revolution. Seamless Migration: Composable Storefronts and Accelerators The webinar initiated with a comprehensive exploration of seamless migration strategies. You can catch the entire webinar right here !

Compliance

Compliance Licensing Licensing Marketing

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

Agency IQ

MAY 3, 2024

Title Type Comments Close Key Information and Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards Draft Guidance April 30 Early Alzheimer’s Disease: Developing Drugs for Treatment Draft Guidance May 13 Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the (..)

FDA

FDA Science Regulations Clinical Trials

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

Agency IQ

JUNE 2, 2023

The following PDUFA dates were obtained from publicly available sources.

FDA

FDA Science Regulations Production

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

Agency IQ

AUGUST 2, 2024

The following PDUFA dates were obtained from publicly available sources.

FDA

FDA Science Regulations Biosimilars

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

Agency IQ

JUNE 29, 2023

The following PDUFA dates were obtained from publicly available sources.

FDA

FDA Science Regulations Production

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

Agency IQ

OCTOBER 27, 2023

and Annex 1 Conference Joel Welch December 18 RAPS RAPS Webcast: FDA Forecast: What’s Next for the FDA in 2024 AgencyIQ Speakers December 21 HL7 REMS Public Call PDUFA Dates expected in November and December PDUFA dates represent the expected date of a regulatory decision by the FDA on a New Drug Application or Biologics License Application.

FDA

FDA Science Regulations Production

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

Agency IQ

SEPTEMBER 29, 2023

The following legislative requirements are due within the next two months: Legislation Program Tag Requirement Due Date FDORA, Section 3202 Orphan Drug Program FDA shall publish final guidance related to the draft guidance titled, “Rare Diseases: Common Issues in Drug Development.”

FDA

FDA Science Regulations Production

BioLineRx Announces Final Results from Phase 2a COMBAT/KEYNOTE-202 Triple Combination Study of Motixafortide in Second Line Metastatic Pancreatic Cancer (PDAC)

The Pharma Data

DECEMBER 15, 2020

Company plans to meet with regulatory authorities as it evaluates next development steps. Company to host Key Opinion Leader (KOL) webinar to discuss these results today, December 16, at 8:00 am EST; registration link below. Interested parties can register for the webinar here. Kenilworth, N.J. ,

Clinical Trials

Clinical Trials Trials Therapies Treatment

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.

FDA

FDA Science Clinical Trials Regulations

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

Agency IQ

DECEMBER 1, 2023

Date Company Drug November 30 Takeda/HUTCHMED Fruquintinib December 8 Vertex / CRISPR Therapeutics Exagamglogene autotemcel December 16 Arcutis Roflumilast December 16 Optinose XHANCE December 16 Merck KEYTRUDA Delayed (Orig. Prohaska, Kavita C. The following PDUFA dates were obtained from publicly available sources.

FDA

FDA Science Regulations Production

Article FDA Thank You Facing headwinds, FDA moves ahead on diagnostics policy implementation but faces Congressional, legal, and judicial questions

Agency IQ

JULY 22, 2024

Facing headwinds, FDA moves ahead on diagnostics policy implementation but faces Congressional, legal, and judicial questions In April 2024, the FDA issued a final rule to update its regulatory approach to certain test products known as Laboratory Developed Tests (LDTs). AgencyIQ provides a status update for regulated industry.

FDA

FDA Laboratories Regulations Clinical Trials

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

Agency IQ

FEBRUARY 2, 2024

The following PDUFA dates were obtained from publicly available sources.

FDA

FDA Science Clinical Trials Regulations

Drug Discovery Digest

6 Operational Considerations You Need To Know for Psychedelic Trials

Unlocking Innovation: A Composable Commerce Approach to Headless with SAP Commerce

Trending Sources

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

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

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

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

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 October 2023

BioLineRx Announces Final Results from Phase 2a COMBAT/KEYNOTE-202 Triple Combination Study of Motixafortide in Second Line Metastatic Pancreatic Cancer (PDAC)

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 December 2023

Article FDA Thank You Facing headwinds, FDA moves ahead on diagnostics policy implementation but faces Congressional, legal, and judicial questions

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

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