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June 3, 2020

Medical Imaging Drugs Advisory Committee Charter

Authority The Medical Imaging Drugs Advisory Committee was established under 15 U.S.C. 1451 et seq.; 21 U.S.C. 321, 341, 342, 343, 343-1, 344, 345, 346, 348, 349, […]
June 3, 2020

Arthritis Advisory Committee Charter

Committee’s Official Designation (Title) Arthritis Advisory Committee Authority The Arthritis Advisory Committee was established under 15 U.S.C. 1451 et seq.; 21 U.S.C. 321, 341, 342, 343, […]
June 2, 2020

MBI Distributing, Inc. Issues Voluntary Nationwide Recall of Homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir Due to a Lack of Process Controls

Summary Company Announcement Date: May 18, 2018 FDA Publish Date: March 30, 2020 Product Type: DrugsGeneric Drugs Reason for Announcement: Recall Reason Description Lack of Adequate […]
June 2, 2020

Coronavirus (COVID-19) Update: Daily Roundup June 2, 2020

For Immediate Release: June 02, 2020 The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 […]
June 2, 2020

Epinephrine Auto-Injector Devices by Amneal and Impax: CDER Alert – FDA Alerts Patients and Health Care Professionals About Device Malfunction

[Posted 06/01/2020] AUDIENCE: Patient, Health Professional, Pharmacy, Risk Manager ISSUE: FDA is alerting patients, caregivers and health care professionals to immediately inspect certain lots of Amneal and […]
June 2, 2020

Institutional Review Board (IRB) Review of Individual Patient Expanded Access Requests for Investigational Drugs and Biological Products During the COVID-19 Public Health Emergency Guidance for IRBs and Clinical Investigators

Docket Number: FDA-2020-D-1414 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research FDA plays a critical role in protecting the United States from threats […]
June 2, 2020

Natural Solutions Foundation – 605748 – 05/19/2020

WARNING LETTER Date : May 19, 2020 TO: [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected] [email protected] Solutions Foundation58 Plotts RdNewton, NJ 07860-6224 RE: Unapproved and Misbranded Products Related to Coronavirus […]
June 2, 2020

UPDATED AGENDA AND PUBLIC PARTICIPATION INFORMATION: June 17-18, 2020: Meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee (pedsODAC) – 06/17/2020 – 06/18/2020

On This Page Date: June 17 – 18, 2020 Time: 10:00 AM – 3:30 PM ET UPDATED INFORMATION (as of 6/2/2020): The Agenda portion has been […]
June 2, 2020

Hospira Issues a Voluntary Nationwide Recall for Hydromorphone HCL Injection, USP CII Due to the Potential for Empty or Cracked Glass Vials

Summary Company Announcement Date: March 05, 2018 FDA Publish Date: April 13, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to The Potential […]
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