FDA IND Approval Process2 Nov 2023 17:38
This might shed more light on the proceedure and timescales:
'FDA IND Review Team
The review team consists of a group of specialists in different scientific fields. Each member has different responsibilities.
Project Manager: Coordinates the team’s activities throughout the review process, and is the primary contact for the sponsor.
Medical Officer: Reviews all clinical study information and data before, during, and after the trial is complete.
Statistician: Interprets clinical trial designs and data, and works closely with the medical officer to evaluate protocols and safety and efficacy data.
Pharmacologist: Reviews preclinical studies.
Pharmakineticist: Focuses on the drug’s absorption, distribution, metabolism, and excretion processes.Interprets blood-level data at different time intervals from clinical trials, as a way to assess drug dosages and administration schedules.
Chemist: Evaluates a drug’s chemical compounds. Analyzes how a drug was made and its stability, quality control, continuity, the presence of impurities, etc.
Microbiologist: Reviews the data submitted, if the product is an antimicrobial product, to assess response across different classes of microbes.
Approval
The FDA review team has 30 days to review the original IND submission. The process protects volunteers who participate in clinical trials from unreasonable and significant risk in clinical trials. FDA responds to IND applications in one of two ways:
Approval to begin clinical trials.
Clinical hold to delay or stop the investigation. FDA can place a clinical hold for specific reasons, including:
Participants are exposed to unreasonable or significant risk.
Investigators are not qualified.
Materials for the volunteer participants are misleading.
The IND application does not include enough information about the trial’s risks.
A clinical hold is rare; instead, FDA often provides comments intended to improve the quality of a clinical trial. In most cases, if FDA is satisfied that the trial meets Federal standards, the applicant is allowed to proceed with the proposed study.
The developer is responsible for informing the review team about new protocols, as well as serious side effects seen during the trial. This information ensures that the team can monitor the trials carefully for signs of any problems. After the trial ends, researchers must submit study reports.'
https://www.fda.gov/patients/drug-development-process/step-3-clinical-research#The_Investigational_New_Drug_Process
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