Agency IQ

JUNE 2, 2023

OIG claims a review will be complete in 2024. July 1, 2023 MDUFA Finalize the draft guidance, “Content of Premarket Submissions for Device Software Functions,” by 18 months from close of the comment period.

FDA 40

FDA Science Regulations Compliance 40

Drug Discovery World

NOVEMBER 8, 2023

Ahead of protein and antibody engineering conference PEGS Europe 2024 in Lisbon, DDW’s Megan Thomas looks at what to expect from each track of the annual biologics technology meeting. Chairperson Mark Chiu, on: ‘Strategies to enhance efficacy of a tetraspecific antibody to TNBC and PDAC’.

Engineering 162

Engineering Protein Expression Therapies Science 162

Drug Discovery World

NOVEMBER 9, 2023

Ahead of protein and antibody engineering conference PEGS Europe 2024 in Lisbon, DDW’s Megan Thomas looks at what to expect from each track of the annual biologics technology meeting. Anthony Stajduhar, Director of Global Business Development, Business Development, Rapid Novor, on: ‘Antibody discovery dead ends and new approaches’.

Engineering 130

Engineering Protein Production Therapies Science 130

Agency IQ

JUNE 16, 2023

The Agenda also includes several long-term actions expected to take place in 2024 and 2025 – included as part of FDA’s long-term regulatory agenda. The anticipated date of publication is June 2023, meaning we should see this regulation imminently. fit in this definition.

Regulations 40

Regulations FDA Science Production 40

Agency IQ

DECEMBER 1, 2023

and Annex 1 Conference Joel Welch December 12 AgencyIQ Looking ahead to 2024: Regulatory Forecast for the U.S. and Annex 1 Conference Joel Welch December 12 AgencyIQ Looking ahead to 2024: Regulatory Forecast for the U.S.

FDA 40

FDA Science Regulations Production 40

Agency IQ

FEBRUARY 23, 2024

On the first day, discussants looked at how to tackle first-in human trials, weighed the importance of the maximum tolerated dose, and looked at the evolving concept of the clinical utility index. LILLIAN SIU, an oncologist and clinical trialist at Toronto’s Princess Margaret Cancer Centre, was a panelist on the day’s second session.

Science 40

Science FDA Trials Clinical Pharmacology 40

Agency IQ

SEPTEMBER 29, 2023

AgencyIQ November 27 DSCSA Technically goes into full effect While the FDA has technically extended enforcement of certain provisions under the Drug Supply Chain Security Act until November 2024, certain provisions of the law are still due to come into effect in late November.

FDA 40

FDA Science Regulations Production 40

Agency IQ

DECEMBER 11, 2023

Diagnostic and therapeutic advances in oncology have moved many cancer types into the categories of curable or treatable diseases. That’s why, according to FDA’s Oncology Center of Excellence, the determination of an appropriate endpoint in oncology is based on the specific disease and is highly dependent upon numerous factors.

FDA 40

FDA Science Clinical Trials Trials 40

Agency IQ

OCTOBER 27, 2023

The date on which the FDA would no longer have Congressionally-appropriated funding with which to continue its operations POLITICO / AgencyIQ November 27 DSCSA Technically goes into full effect While the FDA has technically extended enforcement of certain provisions under the Drug Supply Chain Security Act until November 2024, certain provisions of (..)

FDA 40

FDA Science Regulations Production 40