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recently reported that “Approximately one year ago, on New Years Eve [2015], FDA surprised the device industry with a draft guidance on emerging postmarket device signals.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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FDA Issues Guidance Revision 2: ANDA Submissions – Refuse-to-Receive Standards

According to FDAnews Drug Daily Bulletin, “The FDA has again updated guidance on its criteria for refusing to receive an ANDA, providing a broader definition for major deficiencies and downgrading four major deficiencies to minor ones in order to make requirements less burdensome for industry. In a second revision to the final guidance since last year,…

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FDA Issues Two Important New Biosimilar Guidances

January 17, 2017: “FDA released Draft Guidance for Industry: “Considerations in Demonstrating Interchangeability With a Reference Product.” The guidance provides an overview of important scientific considerations in demonstrating interchangeability and is intended to assist applicants in demonstrating that a proposed therapeutic protein product (e.g., monoclonal antibodies) is interchangeable with a reference product under section 351(k)…

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Seven Noteworthy 505(b)(2) Submissions

Seven Noteworthy 505(b)(2) Submissions

As 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. Generic companies…

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FDA Publishes Final Rule on Postmarketing Safety Reporting for Combination Products

On December 20, 2016, FDA announced a final rule (Docket No. FDA-2008-N-0424) describing the postmarketing safety reporting requirements when two or more different types of regulated medical products are marketed as a combination product. The new rule is meant to ensure complete postmarketing safety reporting and to avoid duplicative reporting.  The postmarketing safety reporting requirements…

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FDA Posts Webinar Describing New Medical Device Reporting Requirements

Last month, we reported that New Guidance on Medical Device Reporting Supersedes Guidance in Use Since 1997. This guidance document is intended to assist medical device manufacturers meet applicable reporting and recordkeeping requirements for certain device-related adverse events and malfunctions. There have been numerous changes to the medical device reporting requirements since the FD&C Act…

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