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By David Ridley 08 Dec 2020
Europe’s self-care industry has “learned its lessons,” particularly in terms of securing the pharmaceutical ingredient supply chain, and will come out of the coronavirus pandemic stronger, insisted AESGP president Birgit Schuhbauer at the BAH’s High-Level Conference on Future Drug Supply in the European Union.
By Malcolm Spicer 27 Jan 2020
CDER Office of New Drugs changes its organization including establishing Office of Nonprescription Drugs and splitting the office into Division of Nonprescription Drug Products I and DNDP II. A Division of Regulatory Operations for Nonprescription Drugs will be comprised of regulatory staff from the ONPD divisions and will report to OND’s regulatory office. Non-clinical ONPD staff will report to the office director.
15 Jan 2020
In addition to Sanofi, firms recalling OTC ranitidine products with documentation included in FDA's database updates through 9 January are Amneal Pharmaceuticals, Preferred Pharmaceuticals, which distributed products made by Amneal, and Granules India Ltd.
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