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Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards Draft Guidance April 30 Early Alzheimer’s Disease: Developing Drugs for Treatment Draft Guidance May 13 Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the (..)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 40

FDA Science Regulations Clinical Trials 40

Agency IQ

AUGUST 2, 2024

Start Date End Date Event Event Type Center 07/30/2024 07/30/2024 Environmental Monitoring in Compounding Virtual CDER 08/02/2024 08/02/2024 UPDATED PUBLIC PARTICIPATION INFORMATION: August 2, 2024: Meeting of the Genetic Metabolic Diseases Advisory Committee Meeting Announcement Advisory Committee Meeting CDER 08/07/2024 08/07/2024 Medical Device (..)

FDA 40

FDA Science Regulations Biosimilars 40

Agency IQ

APRIL 12, 2024

In drug development, biochemical assays might be used to determine a product’s binding affinity to a target receptor of interest, along with the strength, stability and duration of the target-ligand complex after the product binds to the receptor. What does progressive implementation of a potency assurance strategy mean?

Production 40

Production FDA Therapies Biochemical Assays 40

Alta Sciences

AUGUST 15, 2023

Sterilization also takes place after formulation, once the product has been filled into the primary packaging, making it the optimal choice. Learn more about our expertise and find out if terminal sterilization is suitable for your product. Speak with one of our experts.

Packaging 40

Packaging FDA Production Pharmaceuticals 40

Drug Discovery World

FEBRUARY 6, 2023

This approach has led to the development of two software packages for RNA sequencing analysis and reproducible ribosomal profiling 1,2. We also developed an R package to determine optimal gene filtering cut offs and modeled statistical power to detect DE genes for a range of sample sizes, effect sizes, and coverage depths 3.

Bioinformatics 130

Bioinformatics RNA Vaccine Clinical Trials 130

Agency IQ

OCTOBER 27, 2023

December 2023 Fixed-Combination and Co-Packaged Drugs: Applications for Approval and Combinations of Active Ingredients Under Consideration for Inclusion in an Over-the-Counter Monograph (Final Rule) The final rule amends FDA regulations on fixed-combination prescription and nonprescription drugs.

FDA 40

FDA Science Regulations Production 40

Agency IQ

DECEMBER 1, 2023

December 2023 Fixed-Combination and Co-Packaged Drugs: Applications for Approval and Combinations of Active Ingredients Under Consideration for Inclusion in an Over-the-Counter Monograph (Final Rule) The final rule amends FDA regulations on fixed-combination prescription and nonprescription drugs. Prohaska, Kavita C.

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FDA Science Regulations Production 40