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December 15, 2022

Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims

Docket Number: FDA-2008-D-0150 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance is intended to assist applicants in developing labeling for cardiovascular […]
December 15, 2022

Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection (December 2022)

Docket Number: FDA-2013-D-0710 Issued by: Guidance Issuing Office Office of Regulatory Affairs Center for Drug Evaluation and Research Center for Devices and Radiological Health The Food […]
December 15, 2022

FDA-EMA Parallel Scientific Advice Pilot Program for Complex Generic/Hybrid Products

FDA and European Medicines Agency (EMA) have launched a pilot program to provide parallel scientific advice (PSA) to applicants of abbreviated new drug applications (ANDAs) for […]
December 14, 2022

Medical Countermeasure Monitoring and Assessment

Image CaptionElectronic health records are an important part of post-dispensing medical countermeasure monitoring and assessment Background | FDA Guidance & Regulatory Information | Contact | FDA […]
December 14, 2022

Pulmonary Tuberculosis: Developing Drugs for Treatment

Submit Comments by 02/13/2023 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 […]
December 13, 2022

eCTD Submission Standards for eCTD v3.2.2 and Regional M1

eCTD Technical Conformance Guide Documentation and Resources 1.8 Final Guidance for Industry: Providing Regulatory Submissions in Electronic Format – eCTD Specifications 11/04/2022     eCTD Backbone […]
December 13, 2022

Review and Approval

All FDA-approved biological products (biologics), including biosimilars and interchangeable biosimilars, undergo a rigorous evaluation so that health care providers and patients can be confident of the […]
December 13, 2022

Overview for Health Care Professionals

Biosimilars approved by the FDA are safe and effective biological medications. The availability of biosimilars can provide patients with more treatment options, increase access to lifesaving […]
December 13, 2022

Basics for Patients

En Español  Biosimilars are safe and effective medications for treating many illnesses such as chronic skin and bowel diseases (like psoriasis, irritable bowel syndrome, Crohn’s disease […]
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