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Pfizer Subsidiary Hit with Warning Letter for CGMP, Reporting Problems

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A warning letter sent to an Italian subsidiary of Pfizer, Wyeth Lederle S.p.A., by the US Food and Drug Administration (FDA) claims that the company's Catania, Italy manufacturing facility has Read More...

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CGMP

FDA

Italy

Pfizer

Reporting

warning letter

Wyeth

Italian Regulators Call for Clinical Data to be Disaggregated by Gender

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The Italian national regulatory agency, AIFA, has called upon pharmaceutical companies to include gender-disaggregated data in the submission of regulatory documents, including marketing approval Read More...

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Clinical Data

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Gender Disaggregation

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women

Italy Faces Regulatory Hurdles After Earthquakes Slam Life Science Industry

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It’s an ongoing challenge for companies to get products and manufacturing facilities approved by regulatory authorities—and that’s before natural disasters strike, potentially leaving their research Read More...

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Disaster

Earthquakes

Facilities

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Manufacturing

RF Today is Regulatory Focus' daily news brief. Each edition contains the top global regulatory news stories about pharmaceuticals, medical devices, biotechnology and more. Learn more

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Pfizer Subsidiary Hit with Warning Letter for CGMP, Reporting Problems

Italian Regulators Call for Clinical Data to be Disaggregated by Gender

Italy Faces Regulatory Hurdles After Earthquakes Slam Life Science Industry

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