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April 13, 2021

Coronavirus (COVID-19) Update: April 13, 2021

Boilerplate The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of […]
April 13, 2021

Mifeprex (mifepristone) Information

Mifeprex is used, together with another medication called misoprostol, to end an early pregnancy. The FDA first approved Mifeprex in 2000. In 2016, the agency approved […]
April 13, 2021

MYM Hidrominerales S.A. de C.V. – 610066 – 04/09/2021

Delivery Method: VIA UPS Product: Drugs Recipient: Recipient Name Mr. Alberto De La Torre Recipient Title Managing Partner MYM Hidrominerales S.A. de C.V. Avenida 5 De […]
April 12, 2021

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

On This Page Date: May 21, 2021 Time: 1:00 PM – 3:00 PM ET FDA is planning to implement eCTD validations in 2021 specific to submissions […]
April 10, 2021

MedWatch: The FDA Safety Information and Adverse Event Reporting Program

MedWatch, the FDA’s medical product safety reporting program for health professionals, patients and consumers. MedWatch receives reports from the public and when appropriate, publishes safety alerts […]
April 9, 2021

NS NY Distributor Inc Issues Voluntary Nationwide Recall of Premium OrgaZen 7000 and Ginseng Power 5000 Due to Presence of Undeclared Sildenafil and/or Tadalafil

Summary Company Announcement Date: April 08, 2021 FDA Publish Date: April 09, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Undeclared Sildenafil and/or Tadalafil […]
April 9, 2021

DDT COA #000116: PROMIS Itch Questionnaire – Children Impact (PIQ-C-Impact)

Clinical Outcome Assessments (COA) Qualification SubmissionsOffice of Immunology and Inflammation (OII)Division of Dermatology and Dentistry (DDD) DDT COA NumberDDT COA #000116 Instrument NamePROMIS Itch Questionnaire – […]
April 9, 2021

DDT COA #000140: PROMIS Itch Questionnaire – Children Symptom (PIQ-C-Symptom)

Clinical Outcome Assessments (COA) Qualification SubmissionsOffice of Immunology and Inflammation (OII)Division of Dermatology and Dentistry (DDD) DDT COA NumberDDT COA #000140 Instrument NamePROMIS Itch Questionnaire – […]
April 9, 2021

FDA D.I.S.C.O. Burst Edition: FDA approval of ABECMA (idecabtagene vicleucel) the first FDA approved cell-based gene therapy for the treatment of adult patients with relapsed or refractory multiple myeloma

Podcast Welcome back to the D.I.S.C.O., FDA’s Drug Information Soundcast in Clinical Oncology, Burst Edition, brought to you by FDA’s Division of Drug Information in partnership […]
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