Clinical Research Solutions
Clinical Pharmacology Considerations for Oligonucleotides
For the first time, the FDA has issued a draft guidance for industry on “Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics”. Oligonucleotides are short single...
Clinical Research Solutions
Use of Circulating Tumor Deoxyribonucleic Acid for Early-Stage Solid Tumor Drug Development; Draft Guidance for Industry; Availability
May 2022 Guidance Document Download the Final Guidance Document The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Use of...