Generic Pharmaceutical Association (GPhA) Now Association for Accessible Medications (AAM)

GPhA announced at the 2017 Annual Meeting that they are adopting a new name.  Now known as Association for Accessible Medications (AAM), PDG extends its sincere thanks to their staff and fellow participants for making the meeting a good one.  We congratulate our $100 Visa gift-card winner, and particularly enjoyed the keynote speaker, Captain “Sully” Sullenberger. …

Details
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…

Details

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…

Details

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…

Details