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Clinical Research Solutions

FDA Solicits Feedback on ANDA Submissions – Amendments to ANDAs Under GDUFA Guidance, Appendix A

Ahead of this year’s reauthorization of the Generic Drug User Fee Amendments (GDUFA) , FDA has established a docket to solicit comments on the content of Appendix A in the July 2018 guidance for...

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Clinical Research Solutions

FDA publishes product-specific guidances to facilitate generic drug development

Today, FDA published a new batch of product-specific guidances (PSGs). PSGs provide recommendations for developing generic drugs and generating the evidence needed to support abbreviated new drug...

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Clinical Research Solutions

FDA announces guidance for industry titled Changes to Disposable Manufacturing Materials: Questions and Answers

Today, FDA is announcing the availability of a level 2 guidance for industry titled, Changes to Disposable Manufacturing Materials: Questions and Answers. FDA receives questions about the limited...

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Clinical Research Solutions

FDA publishes two final guidances for industry: Orange Book Questions and Answers; Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe

July 2022 As part of FDA’s continued efforts to improve transparency and provide helpful information to regulated industry and the public, the agency is issuing two final guidances for generic drug...

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Clinical Research Solutions

Providing Regulatory Submissions in Alternate Electronic Format Guidance for Industry

Final Guidance June 2022 This guidance provides recommendations on an alternate electronic format for submissions covered under an exemption from or a waiver of the requirements of section 745A(a) of...

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Clinical Research Solutions

How to Interpret FDA’s Final Guidance - “Assessing the Effects of Food on Drugs in INDs and NDAs - Clinical Pharmacology Considerations”

On June 23, 2022, The FDA issued the final version of its Guidance for Industry titled “Assessing the Effects of Food on Drugs in INDs and NDAs - Clinical Pharmacology Considerations”. The most...

Clinical Research Solutions

FDA publishes MAPP 5223.6, Assessment of the User Interface of a Drug-Device Combination Product Submitted in a Pre-ANDA Communication or an ANDA

Today, FDA published a new Manual of Policies and Procedures (MAPP), “Assessment of the User Interface of a Drug-Device Combination Product Submitted in a Pre-ANDA Communication or an ANDA (5223.6).”...

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Clinical Research Solutions

Providing Submissions in Electronic Format — Postmarketing Safety Reports

GUIDANCE DOCUMENT April 2022 This guidance is one in a series of guidance documents intended to assist industry when making certain regulatory submissions in electronic format to FDA’s Center for...

Clinical Research Solutions

How GDUFA II Impacts the Timing and Approval Process for Generic Drug Sponsors

How GDUFA II Impacts the Timing and Approval Process for Generic Drug Sponsors: Facing several regulatory challenges related to the review of abbreviated new drug applications (ANDAs), Congress first...

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Clinical Research Solutions

The Importance of the eCTD Structure for FDA Approval

The Importance of the eCTD To harmonize the process of regulatory reviews for global drug development, a unified structure was developed and implemented for electronic Common Technical Document...

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