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Compounders Press FDA For Revised MOU
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FDA: Take Lifecycle Approach to Analytical Methods Validation
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EMA Outlines Requirements for Manufacturing Finished Dosage Forms
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New Excipient GMPs in EU Take Effect in March
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FDA Revokes Duplicative GST Requirements for Biologics
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House Approves 21st Century Cures Act, Senate Bill in the Works
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Appeals Court Invalidates The Medicines Co.’s Angiomax Patents
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Compulsory Licensing Is Up to Member States, EC Says
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Bill Would Help Generics Makers Obtain Product Samples
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FDA Cracks Down on Companies for Not Paying GDUFA Fees
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FDA Releases Bioequivalence Guidance for 43 Drug Products
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EMA Pilots Early Interaction Meeting to Speed Pediatric Drugs
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