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Analysis Life Sciences Thank You FDA’s nonprescription advisors find no efficacy for phenylephrine

Agency IQ

BY AMANDA CONTI SEP 13, 2023 1:58 PM CDT Quick background on nonprescription drug regulation Nonprescription drugs, also known as over-the-counter (OTC) drugs, are regulated differently than traditional prescription drugs. The FDA will follow these procedures for both agency-initiated operations (e.g.,

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XPhyto Secures Exclusive Psychedelic Drug Development Agreement

The Pharma Data

On August 20, 2018, the Company signed the Exclusive Dealing Agreement with Prof. “Our initial focus is to develop standardized drug formulations with precise, predictable and efficient API delivery for clinical study and therapeutic use.” ” Prof. SOURCE: XPhyto Therapeutics Corp. .

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Analysis Life Sciences Thank You BsUFA III regulatory science pilot offers progress report, fields stakeholder criticisms and questions

Agency IQ

.” Interchangeable products can be substituted for the reference product at the pharmacy level, without prescriber intervention, within state and local regulations. For example, in 2018 the FDA published an extensive draft Q&A guidance document that answered 12 questions related to biosimilar or interchangeable products.

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