FDA
North America
June 30, 2022
Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments
Today, the U.S. Food and Drug Administration (FDA) issued a draft guidance, “Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments.” This...
ANDA
CDER
June 27, 2022
Providing Regulatory Submissions in Alternate Electronic Format Guidance for Industry
Final Guidance June 2022 This guidance provides recommendations on an alternate electronic format for submissions covered under an exemption from or a waiver of the requirements of section 745A(a) of...
ANDA
FDA
June 27, 2022
How to Interpret FDA’s Final Guidance - “Assessing the Effects of Food on Drugs in INDs and NDAs - Clinical Pharmacology Considerations”
On June 23, 2022, The FDA issued the final version of its Guidance for Industry titled “Assessing the Effects of Food on Drugs in INDs and NDAs - Clinical Pharmacology Considerations”. The most...
FDA
North America
June 24, 2022
FDA Issues Draft Guidance for Industry, Considerations for Rescinding Breakthrough Therapy Designation
Draft Guidance June 24, 2022 The U.S. Food and Drug Administration issued a draft guidance for industry titled Considerations for Rescinding Breakthrough Therapy Designation. This draft guidance...
FDA
North America
June 23, 2022
FDA revises 2013 guidance for Non-Penicillin Beta-Lactam Drugs
Draft Guidance June 2022 FDA is announcing the availability of a draft guidance titled, "Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination." This guidance revises...
FDA
EMA
June 22, 2022
Maximising on Scientific Advice Procedures in Europe
A unique opportunity to interact with medicine regulators in Europe Are you considering requesting scientific advice in Europe? We can help you navigate the various procedures within the European...
FDA
North America
June 21, 2022
Non-Clinical Performance Assessment of Tissue Containment Systems Used During Power Morcellation Procedures
June 2022 Draft Guidance for Industry and Food and Drug Administration Staff Introduction This draft guidance document provides recommendations that may help manufacturers comply with the special...
FDA
North America
June 17, 2022
Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket Submissions
Guidance Document Guidance for Industry and Food and Drug Administration Staff JUNE 2022 This guidance document provides FDA's recommendations on the information, technical performance assessment,...
FDA
North America
June 16, 2022
Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies
Guidance Document Draft Guidance for Industry June 2022 This guidance describes a standards recognition program for regenerative medicine therapies (SRP-RMT) at FDA’s Center for Biologics Evaluation...