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May 28, 2021

OCLO LLC/OCLO Nanotechnology Science – 614310 – 05/27/2021

Product: Drugs Recipient: Recipient Name Ricardo Garcia OCLO LLC/OCLO Nanotechnology Science 220 SW 9th Ave, #506Hallandale, FL 33009United States [email protected] RE:                  Unapproved and Misbranded Products Related […]
May 27, 2021

FDA Study Data Technical Rejection Criteria (TRC): What you need to know! – 05/21/2021 – 05/27/2021

On This Page Date: May 21 – 27, 2021 Time: 1:00 PM – 2:30 PM ET [embedded content] FDA is planning to implement eCTD validations in […]
May 27, 2021

Common Labeling Deficiencies and Tips for Generic Drug Applications – 05/07/2021 – 05/07/2021

On This Page Date: May 7, 2021 Time: 1:00 PM – 2:00 PM ET [embedded content]  Download Slides Visit the CDER Small Business and Industry Assistance […]
May 27, 2021

FDA approves second PSMA-targeted PET imaging drug for men with prostate cancer

FDA has approved Pylarify (piflufolastat F 18) – a drug for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA) positive lesions in men with […]
May 27, 2021

GDUFA Reauthorization Stakeholder Meetings

FDA is requesting public stakeholders, including patient and consumer advocacy groups, health care professionals, and scientific and academic experts, notify FDA of their intent to participate […]
May 26, 2021

Coronavirus (COVID-19) Update: FDA Authorizes Additional Monoclonal Antibody for Treatment of COVID-19

For Immediate Release: May 26, 2021 Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the investigational monoclonal antibody therapy sotrovimab […]
May 26, 2021

Drug Trials Snapshots: YUPELRI

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 […]
May 26, 2021

Remarks by Acting Commissioner Woodcock to the Association for Accessible Medicines 2021Access! Conference – 05/26/2021

Speech by Janet Woodcock, M.D. Acting Commissioner of Food and Drugs – Food and Drug Administration It is a pleasure to join you for this year’s […]
May 26, 2021

Drug Trials Snapshots: POLIVY

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 […]
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