July 21, 2020

Stason Pharmaceuticals, Inc. – 604889 – 07/08/2020

Delivery Method: Via Email Product: Drugs Recipient: Recipient Name Mr. Harry T. Fan Recipient Title Chief Executive Officer Stason Pharmaceuticals, Inc. 11 MorganIrvine, CA 92618United States […]
July 21, 2020

Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research Guidance for Industry

Submit Comments by 09/21/2020 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 […]
July 21, 2020

Ningbo BST Clean and Care Products Co., Ltd – 587788 – 11/27/2019

Delivery Method: VIA UPS Product: Drugs Recipient: Recipient Name Mr. Jack Wang Recipient Title Owner/President Ningbo BST Clean and Care Products Co., Ltd Xining Road, Xiwu […]
July 20, 2020

LIQ-E S.A. de C.V. Issues Voluntary Recall of the Optimus Instant Hand Sanitizer Due to the Potential Presence of Undeclared Methanol

Summary Company Announcement Date: July 20, 2020 FDA Publish Date: July 20, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential Methanol Contamination Company […]
July 20, 2020

FDA Protects Patients and Consumers from Fraud During COVID-19

Image By: Judy McMeekin, Pharm. D., Associate Commissioner for Regulatory Affairs, and Anand Shah, M.D., Deputy Commissioner for Medical and Scientific Affairs Throughout the pandemic, the […]
July 20, 2020

Building on Successes of the Generic Drug Program, FDA Sets the Stage for the Next Generic Drug User Fee Amendments (GDUFA) Reauthorization Process

In this CDER Conversation, Sally Choe, director of the Center for Drug Evaluation and Research’s (CDER) Office of Generic Drugs and Mike Kopcha director of CDER’s […]
July 20, 2020

FDA’s Continued Commitment to the Safety and Security of Our Laboratories

Image By: Stephen M. Hahn, M.D., Commissioner of Food and Drugs, and RADM Denise Hinton, Chief Scientist The FDA is known for its mission to protect […]
July 20, 2020

New Funding Opportunity: FDA Standard Core Clinical Outcome Assessments (COAs) and Endpoints Pilot Grant Program

CDER Conversation with Robyn Bent, Director of Patient-Focused Drug Development and Program Officer for the FDA Standard Core Clinical Outcome Assessments (COAs) and Endpoints Pilot Grant […]
July 18, 2020

InHe Manufacturing, LLC and MHR Brands Issues Voluntary Nationwide Recall of Several Products Due to Potential Health Risk for Excess Lead

This recall press release was issued by the firm on 06-23-2020 and is subsequently being posted by FDA at this time only to benefit the public […]
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