Pharmacokinetics in Drug Development

Pharmacokinetics in Drug Development Related to ANDA/505(b)(2) Submissions

As pharmaceutical consultants, the scientists and regulatory professionals at PDG® design pharmacokinetic (PK) protocols for a wide variety of applications. This paper has been written to provide the reader with a basic review of pharmacokinetic and pharmacodynamics (PD) principles as well as an exposure to a cross section of the utility of PK studies. While…

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FDA Bans Powdered Surgeon Gloves; Rule Takes Effect January 18, 2017

According to FDA, “A thorough review of all currently available information supports FDA’s conclusion that powdered surgeon’s gloves, powdered patient examination gloves, and absorbable powder for lubricating a surgeon’s glove should be banned. This rule applies to powdered patient examination gloves, powdered surgeon’s gloves, and absorbable powder for lubricating a surgeon’s glove. This includes all…

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Postmarketing Safety Reporting for Combination Products Final Rule Effective January 19, 2017

Last month we reported that FDA Publishes Final Rule for Postmarketing Safety Reporting for Combination Products. This month, we wish to remind you that it has taken effect. The new rule “describes the postmarketing safety reporting requirements that apply when two or more different types of regulated medical products (drugs, devices, and/or biological products, which…

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FDA Issues Final Guidance: Public Notification of Emerging Postmarket Device Signals

FDA Law Blog recently reported that “Approximately one year ago, on New Years Eve [2015], FDA surprised the device industry with a draft guidance on emerging postmarket device signals. On December 14 [2016], FDA issued the final guidance document: Public Notification of Emerging Postmarket Device Signals (“Emerging Signals”) FDA has made significant changes to the draft…

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