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FDA
HHS Issues Declaration Exempting Some from Liability Related to COVID-19…
The Department of Health and Human Services (“HHS”) recently issued a declaration under the Public Readiness and Emergency…
Pharma Offers Suggestions on Reorganizing OND
Following a public meeting at the United States Food and Drug Administration (FDA) in November 2019, a handful of drug makers sent…
CDER Issues New MAPP For REMS Assessment Reviews
The US Food and Drug Administration (“FDA”) recently issued a Manual of Policies and Procedures (“MAPP”) describing how the Center…
FDA OPDP Working on Two Studies to Better Understand Viewer Comprehension
The United States Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) recently announced that it is…
FDA Draft Guidance on Combination Products
Recently, the U.S. Food and Drug Administration (FDA) issued draft guidance on requesting feedback from the agency related to…
FDA Draft Guidance on Drug Development Tools
The U.S. Food and Drug Administration (FDA) on issued draft guidance explaining its qualification process for drug development…
FDA Releases Draft Guidance on Biosimilar Review
Earlier this month, the United States Food and Drug Administration (FDA) issued new draft guidance on how it plans to expedite its…
FDA and FTC Join Forces on Biosimilar Marketing
Earlier this month, the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) released a joint statement about…
FDA and NIH Don’t Always Enforce Clinical Trial Transparency Regulations
Recently, Science magazine reviewed more than 4,700 clinical trials whose results should have been posted on the National…
FDA Announces Plan for Coronavirus Countermeasures
With Coronavirus deaths now over 1,000, the US Food and Drug Administration (“FDA”) announced actions to advance the development…