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FDA Releases Novo Nordisk FDA-483

[ Price : $8.95]

FDA releases a two-item Form FDA-483 citing GMP issues documented at Novo Nordisks Clayton, NC facility during a 7/6-13 inspection...

Government, FDA Shutdown Appearing More Likely

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It appears more likely that the federal government, including FDA, will face a 10/1 shutdown due to a Congressional impasse to app...

PDUFA Formal Meetings Guidance

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Federal Register notice: FDA makes available a draft guidance entitled Formal Meetings Between the FDA and Sponsors or Applicants ...

Guide on Inspection Alternative Tools

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Federal Register notice: FDA makes available a draft guidance entitled Alternative Tools: Assessing Drug Manufacturing Facilities ...

FDA OKs Jardiance in Chronic Kidney Disease

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FDA approves Boehringer Ingelheim and Eli Lillys Jardiance (empagliflozin) 10 mg tablets for treating certain patients with chroni...

Senators Urge FDA to Strengthen Opioid Studies

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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...

Legislation Introduced to Improve Device Recalls

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U.S. Senator Dick Durbin (D-IL) and Representative Jan Schakowsky (D-IL) introduce bicameral legislation to improve the medical de...

Panel Votes Down Intarcia Diabetes Implant

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FDAs Endocrinologic and Metabolic Drugs Advisory Committee votes 19 to 0 against approving Intarcia Therapeutics implantable ITCA ...

PDUFA Formal Meeting Guidance

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FDA publishes a draft guidance with recommendations about formal meetings between FDA and sponsors or applicants relating to drugs...

Drug Manufacturing Alternative Assessment Tools

[ Price : $8.95]

FDA publishes a draft guidance on how it will use alternative tools to assess manufacturing facilities named in NDAs, ANDAs, BLAs,...