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Pharma and Health from Ingredients to Pills: FDA Drug Recalls 101
Lin Zhang
June 15, 2020
Pharmaceutical drug use in the USA dates back more than a century, and the use of these drugs led to creation of new acts or changes to the existing ones.
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Conducting Clinical Trials amid the COVID-19 Outbreak: FDA Encourages Sponsors to Go Virtual
Neeta Ratanghayra
April 08, 2020
For pharmaceutical companies, one of the most significant operational impacts of the COVID-19 is on clinical trials. On March 19, 2020, the U.S. Food and Drug Administration (FDA) issued guidance on the conduct of clinical trials during the COVID-19 pande
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Polpharma Biologics Announces FDA Approval of Tyruko® - First And Only Approved Biosimilar to Tysabri®* for Relapsing Forms of Multiple Sclerosis
PharmaSources
August 28, 2023
On August 25, 2023,Polpharma Biologics announced today that the U.S. Food and Drug Administration (FDA) is the first regulatory body worldwide to approve the use of Tyruko®.
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FDA Inspections of Outsourcing Facilities
FDA
March 31, 2022
Provide an overview of the inspection process for compounding outsourcing facilities.
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Immunogenicity Information in Labeling
FDA
March 25, 2022
This webinar has been approved for 1.5 contact hours of continuing education for pharmacists, physicians, and nurses. Please see detailed announcement for additional information.
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FDA Approves First Generic of Symbicort to Treat Asthma and COPD
FDA
March 17, 2022
Today, the U.S. Food and Drug Administration approved the first generic of Symbicort (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol for the treatment of two common pulmonary health conditions...
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FDA Approves Treatment for Wider Range of Patients with Heart Failure
FDA
February 25, 2022
The U.S. Food and Drug Administration approved Jardiance (empagliflozin) to reduce the risk of cardiovascular death and hospitalization for heart failure in adults.
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Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA
FDA
February 18, 2022
In August 2021, FDA revised the draft guidance for industry on Bioequivalence (BE) Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA to update and clarify the agency’s recommendations...
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Office of Generic Drugs 2021 Annual Report
FDA
February 16, 2022
Welcome to the seventh Annual Report from the Office of Generic Drugs (OGD) in the Center for Drug Evaluation and Research (CDER) of the U.S. Food and Drug Administration (FDA).
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Pfizer and BioNTech to extend rolling submission for Covid-19 vaccine
Pharmaceutical-Technology
February 15, 2022
Pfizer and BioNTech are set to extend their rolling submission to the US Food and Drug Administration (FDA) for amending the emergency use authorization (EUA) of the Covid-19 vaccine to include children aged six months to four years.