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July 31, 2020

Resource Capacity Planning and Modernized Time Reporting

As the science of product development and regulation has grown increasingly complex, the FDA’s human medical product user fee programs have also grown both in the […]
July 29, 2020

Most Recent Changes to the IID Database

The Inactive Ingredient Database (IID) has changed. Under the reauthorization of the Generic Drug User Fee Amendments (GDUFA) for fiscal years 2018-2022, FDA made a commitment […]
July 29, 2020

Drug Trials Snapshots: DARZALEX

HOW TO USE THIS SNAPSHOTThe information provided in Snapshots highlights who participated in the clinical trials that supported the FDA approval of this drug, and whether […]
July 29, 2020

Pathological Complete Response in Neoadjuvant Treatment of High-Risk Early-Stage Breast Cancer: Use as an Endpoint to Support Accelerated Approval

Docket Number: FDA-2012-D-0432 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance is intended to assist sponsors in designing trials to support […]
July 29, 2020

Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products

Docket Number: FDA-2017-D-0829 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The last few decades have seen an increasing demand in various health […]
July 29, 2020

Summitt Labs Issues Voluntary Nationwide Recall of KORE ORGANIC Watermelon CBD Oil Due to High Lead Results

Summary Company Announcement Date: July 28, 2020 FDA Publish Date: July 28, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Contains lead Company Name: […]
July 29, 2020

Broncolin S.A. de C.V. Issues Voluntary Nationwide Recall of Herbacil Antiseptic Hand Sanitizer 70% Alcohol Due to Potential Presence of Undeclared Methanol (Wood Alcohol)

Summary Company Announcement Date: July 27, 2020 FDA Publish Date: July 28, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Undeclared Methanol Company Name: […]
July 28, 2020

Postmarket Requirements and Commitments

Provides information to the public on postmarket requirements and commitments. The phrase postmarket requirements and commitments refers to studies and clinical trials that sponsors conduct after […]
July 28, 2020

Setting Endotoxin Limits During Development of Investigational Oncology Drugs and Biological Products Guidance for Industry

Submit Comments by 10/28/2020 Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment […]
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