January 25, 2023

Patient-Focused Drug Development

The OCE PFDD program has published multiple manuscripts in peer-reviewed journals to advance patient-focused drug development. Some selected articles are listed below: Floor and ceiling effects […]
January 24, 2023

Kadesh Incorporation Issues Voluntary Nationwide Recall of Puriton Eye Relief Drops Due to Non-Sterile Production Conditions

Summary Company Announcement Date: November 07, 2018 FDA Publish Date: March 16, 2020 Product Type: Drugs Over-the-Counter Drugs Reason for Announcement: Recall Reason Description Due to […]
January 24, 2023

Project Orbis

R. Angelo de Claro is a hematology-oncology physician and currently the Associate Director (Acting) for Global Clinical Sciences with the Oncology Center of Excellence. In this […]
January 24, 2023

Buzzagogo, LLC – 639545 – 01/18/2023

Delivery Method: Via Email Product: Drugs Issuing Office: Center for Drug Evaluation and Research | CDER United States WARNING LETTER January 18, 2023 RE: # 639545 […]
January 24, 2023

Larkin Community Hospital Institutional Review Board – 638146 – 01/11/2023

Delivery Method: VIA UNITED PARCEL SERVICE Product: Drugs Recipient: Recipient Name Sima Marzban, M.D. Recipient Title Vice President for Research and Academic Affairs Larkin Community Hospital […]
January 24, 2023

North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding – 642792 – 11/18/2022

Delivery Method: VIA Electronic Mail Product: Drugs Recipient: Recipient Name Mr. Justin K. Graves Recipient Title Vice President North American Custom Laboratories, LLC dba FarmaKeio Superior […]
January 23, 2023

Mpox: Development of Drugs and Biological Products; Guidance for Industry

Submit Comments by 03/21/2023 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 […]
January 23, 2023

Timeline of Selected FDA Activities and Significant Events Addressing Substance Use and Overdose Prevention

1995.  OxyContin (oxycodone controlled-release) approved; first formulation of oxycodone that allowed dosing every 12 hours instead of every 4 to 6 hours.   1998.  Actiq (fentanyl) […]
January 21, 2023

Questions and Answers on Compounded Oral Suspension Medications for Pain and Fever

The US is experiencing a surge in three viruses: COVID-19, respiratory syncytial virus (RSV) and influenza, any of which can cause fevers in young children. FDA […]
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