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January 17, 2017: “FDA released Draft Guidance for Industry: “Considerations in Demonstrating Interchangeability With a Reference Product.”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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FDA Publishes Draft Guidance on Format and Content of Physiologically-Based Pharmacokinetic Analyses

According to the Background, “This guidance outlines the recommended format and content for a sponsor to submit physiologically based pharmacokinetic (PBPK) analyses to the FDA to support applications including investigational new drug (INDs) applications, new drug applications (NDAs), biologics license applications (BLAs), or abbreviated new drug applications (ANDAs). To enable efficient and consistent review, the…

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FDA Reports “Progress & Potential” With Regard to Combination Products

According to FDA Commissioner Robert M. Califf, M.D. and Nina L. Hunter, Ph.D., FDA’s Associate Director for Science Policy in the Office of Medical Products and Tobacco, “About a year ago, we shared with you our Combination Product Review, Intercenter Consult Process Study Report, which was developed by FDA’s Office of Planning. The report’s findings were…

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President Signs 21st Century Cures Act Into Law, FDA Commissioner Comments

The Washington Post recently reported that “The bill provides for $4.8 billion in new funding for the National Institutes of Health; of that, $1.8 billion is reserved for the “cancer moonshot” launched by Vice President Biden to accelerate research in that field. Another $1.6 billion is earmarked for brain diseases including Alzheimer’s. Also included are…

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Senator Offers President-Elect Help Bringing Drug Prices Down

FiercePharma recently reported “Trump wants to battle high drug prices? Let’s work together, hike-fighting senator says.”  In the story, Sen. Amy Klobuchar (D-Minnesota), has a message for President-elect Donald Trump: “Let’s bring drug prices down together… In a new op-ed for USA Today, Sen. Klobuchar outlined several tactics that, if implemented, would reduce prices in the U.S., she…

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