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FDA releases a two-item Form FDA-483 citing GMP issues documented at Novo Nordisks Clayton, NC facility during a 7/6-13 inspection...[ Price : $8.95]
It appears more likely that the federal government, including FDA, will face a 10/1 shutdown due to a Congressional impasse to app...[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Formal Meetings Between the FDA and Sponsors or Applicants ...[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Alternative Tools: Assessing Drug Manufacturing Facilities ...[ Price : $8.95]
FDA approves Boehringer Ingelheim and Eli Lillys Jardiance (empagliflozin) 10 mg tablets for treating certain patients with chroni...[ Price : $8.95]
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 ...