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Food and Drug Administration (FDA) › Applications

King & Spalding

Predetermined Change Control Plans (PCCPs) for Medical Devices: FDA Issues Draft Guidance

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On August 22, 2024, the U.S. Food and Drug Administration (FDA or Agency) issued a draft guidance entitled, Predetermined Change Control Plans for Medical Devices. The draft guidance describes how FDA plans to implement new...more

Mintz - Intellectual Property Viewpoints

Federal Circuit Affirms Obviousness of Rifaximin Polymorph Patents and Denial of Motion to Modify Judgment After Post-Trial...

Mintz - Intellectual Property Viewpoints on

In a precedential opinion issued on April 11, 2024 in Salix Pharmaceuticals, Ltd. v. Norwich Pharmaceuticals Inc., Nos. 22-2153, 23-1952, the U.S. Court of Appeals for the Federal Circuit affirmed the U.S. District Court for...more

King & Spalding

FDA Issues Draft Guidance on Use of “Generally Accepted Scientific Knowledge” to Support Drug and Biologic Applications

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Could Help to Streamline Development and Approval - On May 25, 2023, the Food and Drug Administration (“FDA” or the “Agency”) announced the availability of a new Draft Guidance for Industry, Generally Accepted Scientific...more

Hogan Lovells

FDA issues benefit-risk framework for assessing opioid drug applications, announces public meeting

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Agency seeks input on “comparative advantage” requirement for new opioids - Yesterday, as part of its ongoing efforts to combat the current opioid crisis, FDA published a draft guidance, “Opioid Analgesic Drugs:...more

Hogan Lovells

The FDA now offers cGMP Declarations

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The United States Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Export Certificate office, a new online application. ...more

Knobbe Martens

China Drug Administration Proposes Pharmaceutical Data Protection Guidelines

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On April 26, 2018, the China Drug Administration (CDA) released a draft guideline of implementing rules on pharmaceutical data exclusivity for public comments. The draft guideline expands the scope of data protection from...more

Goodwin

FDA Releases New “Refuse to File” Guidance

Goodwin on

The FDA has announced a draft guidance, titled “Refuse to File: NDA and BLA Submissions to CDER.” The guidance is intended to clarify the circumstances where the CDER (Center for Drug Evaluation and Research) may refuse to...more

Jones Day

FDA Establishes Electronic Privacy, Security, and Reliability Criteria for Clinical Trial Records

Jones Day on

In March 1997, the Food and Drug Administration ("FDA") published a final rule, codified in 21 CFR Part 11 ("Part 11"), establishing the privacy, security, and reliability criteria for electronic records and electronic...more

Kelley Drye & Warren LLP

FDA Stays Final Guidance on INDs for Foods and Dietary Supplement Studies

Kelley Drye & Warren LLP on

On October 30, 2015, the U.S. Food and Drug Administration announced that it was staying portions of its controversial Final Guidance relating to the types of studies that require compliance with Investigational New Drug...more

McGuireWoods LLP

Biological v. Biosimilar: “860? is the Magic Burden Per Response Number for Now

McGuireWoods LLP on

On February 3, 2015, FDA published a notice in the Federal Register requesting comments on information collection in an application for a proposed biosimilar and a supplement for a proposed interchangeable product....more

K&L Gates LLP

FDA Accepts First Biosimilar Application Filed under Section 351(k) of the Public Health Service Act

K&L Gates LLP on

Biologics are large molecules made from, derived from, or extracted from a natural source such as a human, animal, or microorganism that are used in the treatment, diagnosis, or prevention of disease. Biologics include...more

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