The US FDA has published the final Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format rule

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Inpharma, Vol. 1, Iss. 1418, 2003-01 ,pp. : 3-3

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New legislation aimed at severing the close ties between the US FDA and drug companies has been introduced in the US.

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Inpharma, Vol. 1, Iss. 1488, 2005-01 ,pp. : 21-21

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The US FDA has granted tentative approval to Teva Pharmaceutical's Abbreviated New Drug Application (ANDA) for lansoprazole.

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Inpharma, Vol. 1, Iss. 1623, 2008-01 ,pp. : 19-19

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Astellas Pharma's Supplemental New Drug Application (sNDA) for injectable micafungin [Mycamine] has been approved by the US FDA.

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Inpharma, Vol. 1, Iss. 1623, 2008-01 ,pp. : 18-18

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The US FDA has awarded orphan drug designation to arGentis Pharmaceuticals' ARG 201 [native type 1 bovine collagen] for use in systemic scleroderma.

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Inpharma, Vol. 1, Iss. 1625, 2008-01 ,pp. : 23-23

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