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Pharmaceutical Industry › Food and Drug Administration (FDA) › Applications

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FDA Issues Draft Guidance on Use of “Generally Accepted Scientific Knowledge” to Support Drug and Biologic Applications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- On May 25, 2023, the Food and Drug Administration (“FDA” or the “Agency”) announced the availability of a new Draft Guidance for Industry, Generally Accepted Scientific...more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

Hogan Lovells on

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for new opioids - Yesterday, as part of its ongoing efforts to combat the current opioid crisis, FDA published a draft guidance, “Opioid Analgesic Drugs:...more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

Knobbe Martens on

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The FDA has announced a draft guidance, titled “Refuse to File: NDA and BLA Submissions to CDER.”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

K&L Gates LLP

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

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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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