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Searching Content indexed under Corporate/Commercial Law by Frederick Ball ordered by Published Date Descending.
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FDA Issues Final Guidance On Data Integrity And Compliance With Drug CGMP
Data integrity means complete, consistent and accurate recording of data. This requires an original or true copy of contemporaneously recorded data that is attributable to a specific individual and is legible and accurate.
United States
18 Jan 2019
2
FDA Announces New UDI Compliance Deadlines Via Another Guidance Document
On September 24, 2013, the Food and Drug Administration (FDA) issued a "final" rule regarding the Unique Device Identification System to adequately identify devices through distribution and use
United States
4 Jan 2019
3
CDER's New MAPP On Risk-Based Site Selection Model For Routine Inspections
The list is developed from inputting sites from CDER's Catalog of Manufacturing Sites into the SSM
United States
15 Nov 2018
4
FDA Issues Final Guidance On Quality Agreements In Arrangements For Contract Manufacturing Of Drugs
The U.S. Food and Drug Administration (FDA) has released a final guidance, entitled "Contract Manufacturing Arrangements for Drugs: Quality Agreements," . . .
United States
4 Jan 2017
5
D.C. Circuit Affirms HHS Power To Disqualify Corporate Officials Convicted Of Misdemeanors Under The "Responsible Corporate Official" (RCO) Doctrine
On July 27, 2012, the U.S. Court of Appeals for the D.C. Circuit issued the long-anticipated decision in Friedman v. Sebelius.
United States
14 Aug 2012
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