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Senators Edward Markey (D-MA) and Joe Manchin (D-WV) call on FDA to curb the use of enriched enrollment randomized withdrawal stud...[ Price : $8.95]
U.S. Senator Dick Durbin (D-IL) and Representative Jan Schakowsky (D-IL) introduce bicameral legislation to improve the medical de...[ Price : $8.95]
FDAs Endocrinologic and Metabolic Drugs Advisory Committee votes 19 to 0 against approving Intarcia Therapeutics implantable ITCA ...[ Price : $8.95]
FDA publishes a draft guidance with recommendations about formal meetings between FDA and sponsors or applicants relating to drugs...[ Price : $8.95]
FDA publishes a draft guidance on how it will use alternative tools to assess manufacturing facilities named in NDAs, ANDAs, BLAs,...[ Price : $8.95]
Travere Therapeutics says confirmatory trial data for accelerated approval therapy Filspari (sparsentan) will form the basis of a ...[ Price : $8.95]
Three Hogan Lovells attorneys analyze a recent FDA guidance on using the ISO 10993-1 international standard for medical device bio...[ Price : $8.95]
An NPR report says FDA has received nearly 500 complaints about mental health issues patients associate with using semaglutide dru...