The U.S. Food and Drug Administration (FDA) issued its third draft guidance under the Real-World Evidence (RWE) Program on November 29, 2021. In Real-World Data: Assessing Registries to Support Regulatory Decision-Making for...more
12/9/2021
/ Biologics ,
Clinical Trials ,
Draft Guidance ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Medical Research ,
Pharmaceutical Industry ,
Prescription Drugs ,
Real World Evidence ,
Regulatory Oversight ,
Regulatory Standards
The global pandemic has accelerated the Food and Drug Administration’s (FDA) encouragement of real-world data (RWD) and real-world evidence (RWE) (the clinical evidence derived from analysis of RWD), particularly as the FDA...more
The U.S. Food and Drug Administration (FDA) issued a draft guidance titled Data Standards for Drug and Biological Product Submissions Containing Real-World Data on October 21, 2021. The guidance provides the Agency’s thoughts...more
11/4/2021
/ Biologics ,
Clinical Trials ,
Draft Guidance ,
Food and Drug Administration (FDA) ,
Healthcare ,
Life Sciences ,
Medical Research ,
Pharmaceutical Industry ,
Prescription Drugs ,
Real World Evidence ,
Regulatory Oversight
The FDA issued a final rule (RIN 0910-A147) on August 2, 2021, to clarify its “intended use” regulations for pharmaceutical products and medical devices — 21 CFR §201.128 (drugs) and 21 CFR §801.4 (devices). The final rule...more
8/10/2021
/ Final Rules ,
Food and Drug Act ,
Food and Drug Administration (FDA) ,
Intended Use ,
Life Sciences ,
Medical Devices ,
Off-Label Use ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Amendments ,
Regulatory Oversight ,
Regulatory Reform
The U.S. Food and Drug Administration (FDA) has issued three letters (one warning letter and two untitled letters) over the last two months of 2019 directed at four different companies focused on the processing, distributing,...more
1/15/2020
/ Biologics ,
Distributors ,
FDA Warning Letters ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Manufacturer Liability ,
Marketing ,
Pharmaceutical Industry ,
Public Health Service Act ,
Regenerative Medicine ,
Regulatory Requirements ,
Stem cells
The U.S. Food & Drug Administration’s (FDA’s) Least Burdensome Provisions: Concept and Principles: Guidance for Industry and Food and Drug Administration Staff, February 5, 2019, states that “medical device regulation should...more