According to FDA’s What’s New Related to Drugs, on February 16, CDER published Guidance Agenda: New & Revised Draft Guidances CDER is Planning to Publish During Calendar Year 2017. Here’s a link to the document and here is a link to contact us with your drug development concerns.
Industry Can Notify FDA Drug Shortage Staff via CDER Direct NextGen “The Food and Drug Administration released a new technology platform for Industry to send drug shortage and supply notifications. CDER Direct NextGen allows Industry users to login, enter their shortage information, and submit to the FDA.” Upgraded Drug Shortages app for Android devices…
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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…
DetailsOn January 25, 2017, FDA introduced an important new data update to the Orange Book . Search results and drug listings will now “clarify which listed drugs are reference listed drugs (RLDs) and which are reference standards. Listings also indicate which products in the Discontinued Section may be referred to as an RLD. The FDA…
DetailsAccording to FDAnews Drug Daily Bulletin “FDA said it would not wait for the Federal Register to publish determinations that a reference listed drug’s removal from sale had nothing to do with safety and effectiveness. Previously, the FDA would publish its findings that a drug was removed from the market for reasons other than its…
DetailsThis year’s GPhA Annual Meeting will be held at the JW Marriott Orlando Grande Lakes; Orlando, Florida, February 13 – 15, 2017. If you plan to be there, please be sure to stop by booth #31 and say hello. Our Director of Regulatory Affairs, Mikel Alberdi; Director of Epidemiology, Darren Scheer; and VP of Operations,…
DetailsAccording 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…
DetailsAs drug and device consultants, the scientists and regulatory experts at PDG® spend a considerable amount of time working on 505(b)(2) NDA submissions. This paper highlights notable features of a cross section of recent 505(b)(2) approvals and provides a variety of everyday issues to consider as you contemplate your next drug development project. Click here…
DetailsLast 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…
DetailsFDA 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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