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PDSA Joins Opposition to Florida Drug Importation Program

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The Pharmaceutical Distribution Security Alliance calls on FDA not to authorize Floridas proposal to import drugs from Canada, say...

FDA and Medical Device Regulations in 2021: Analysis

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Attorney Jim Shehan outlines possible FDA 2021 activities involving medical devices.

Akesis Galaxy RTi Radiosurgery Device Cleared

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FDA clears an Akesis 510(k) for the Akesis Galaxy RTi, an advanced gamma stereotactic radiosurgery system with continuous 360-degr...

Dr. Reddys Hit With Form-483 After API Inspection

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A recent inspection at Dr. Reddys Laboratories active pharmaceutical ingredient manufacturing plant in Middleburg, NY cites three ...

FDA Doing Better On Sex, Gender Differences in Drug Development: Study

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Nine FDAers say FDA is doing better accounting for sex and gender differences in drug development.

2 Governors Ask FDA Vaccine Pooling Approval

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Govs. Polis and Brown call on FDA to approve Covid vaccine pooling.

Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that include Evelyn Lopez-Brignoni and Cannafyl.

Author Encouraged by Decade of FDA Drug Approvals

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A review of FDA drug approvals in the last decade covers 378 novel drugs and 27 biosimilars, with 25% of them for oncology indicat...

Objectionable Clinical Trial Practices at Florida Clinic

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FDA warns a Florida doctor about objectionable conditions in the practices conduct of two clinical trials.

Cannafyl Marketing Unapproved Human, Animal CBD Drugs

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FDA warns Cannafyl it is marketing unapproved and misbranded new drugs for use in humans and an unapproved new animal drug.