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The submitted data did not rule out the possibility the proposed formulation could result in more abuse via injection than using a conventional oxycodone formulation. Read More
Health Canada pointed to the last paragraph in the Food and Drugs Act’s definition of a medical device as a significant 2014 addition intended to help distinguish between products. Read More
Brand-name drugs referenced by generics covered by the new guidance include fungal infection treatment, ADHD treatment and Aleve-D Sinus & Cold. Read More
A successful paradigm shift focusing on software is heavily dependent on collaborative interactions, said Bakul Patel, CDRH’s associate director for digital health. Read More