The FDA has released its draft guidance on Risk Evaluation and Mitigation Strategies, or REMS, laying out guidelines for how pharmaceutical companies
Continue Reading FDA Releases Draft Guidance on Risk Evaluation and Mitigation Strategies
biologics
FDA Issues Guidance For Industry On Retaining Data From Clinical Trials
By Sean Wajert on
Posted in Articles, Drug and Device
Limiting mass tort/class action exposure is a key part of the role of in-house litigators. In the drug and device areas, limiting plaintiffs’ ability …
Continue Reading FDA Issues Guidance For Industry On Retaining Data From Clinical Trials
How To Deal With Litigation-Related Concerns In “REMS” For Biologics
By Sean Wajert on
Posted in Articles, Drug and Device
Last year’s Food and Drug Administration Amendments Act gave the FDA increased authority to require Risk Evaluation and Mitigation Strategies (R…
Continue Reading How To Deal With Litigation-Related Concerns In “REMS” For Biologics