All US articles
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Journal
IVD4: How to manage diverging regulatory strategies within a global market (China, US and the EU)
Regulatory Rapporteur December 2023 | Volume 20 | No.11 Session leaders Amanda Brown, Director of Quality and Regulatory Affairs, HP, Germany. Ashleigh Batchen, Regulatory Strategy Principal (UK), TÜV SÜD, UK. Speakers Maurizio Suppo, Vice President ...
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Journal
Regulatory considerations of a growing pharmaceutical company: a UK/US comparison of the generics industry
Generics must demonstrate equivalence to the originator product to gain regulatory approval and market entry. There is a large market for generics that is predicted to continue to grow. The individual price of generics is lower than the originator, nevertheless manufacturers can avoid large development costs to bring generics to ...
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Industry news
FDA approves its first nonprescription birth control pill
FDA approves first over-the-counter (OTC) contraceptive pill for use in the US − it is expected to become the most effective OTC birth control.