The FDA Group Blog
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The FDA Group is a global leader in life science consulting, staff augmentation, recruitment, remediation, auditing, and other quality system services.
The FDA Group Blog
2M ago
The FDA's Quality Management System Regulation (QMSR) final rule amends the Quality System Regulation (QSR) to harmonize and modernize the regulations ..read more
The FDA Group Blog
5M ago
In the dynamic world of medical device manufacturing, understanding and successfully navigating the FDA's 510(k) submission process is crucial ..read more
The FDA Group Blog
5M ago
In the last decade, there has been a significant shift in auditing clinical trials towards a risk-based model. Our approach takes it a step further by incorporating a quality management framework into our clinical audit methodology ..read more
The FDA Group Blog
6M ago
Preparing for regulatory inspections from authorities such as the FDA or EMA involves conducting mock inspections, which is a crucial part of industry inspection readiness ..read more
The FDA Group Blog
6M ago
On September 29, 2023, the FDA proposed a rule that would end the enforcement discretion policy for laboratory-developed tests (LDTs) by treating them as In Vitro Diagnostics (IVDs) subject to regulatory requirements as medical devices ..read more
The FDA Group Blog
6M ago
In the pharmaceutical and medical device industries, regulatory agencies require internal and supplier audits to ensure compliance with Good Manufacturing Practices and ISO standards ..read more
The FDA Group Blog
6M ago
Meeting regulatory and quality compliance in multiple markets is a difficult and complex challenge ..read more
The FDA Group Blog
6M ago
An Abbreviated New Drug Application (ANDA) is a submission to the FDA for the approval of generic drugs, demonstrating that the proposed drug is equivalent in safety, efficacy, and quality to a previously approved reference-listed drug (RLD ..read more
The FDA Group Blog
6M ago
The 505(b)(2) New Drug Application (NDA) provides a streamlined route for drug approval, making it a popular choice among many clients seeking FDA approval. Established by the Hatch-Waxman Amendments of 1984, this pathway refers to a specific section of the Federal Food, Drug, and Cosmetic Act ..read more
The FDA Group Blog
7M ago
From FY2018 - FY2022, 21 CFR 211.22(d) was the second most commonly cited regulation appearing in FDA Warning Letters to drug firms (as analyzed by the FDA's publically available dataset ..read more