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June 21, 2022
June 2022 Draft Guidance for Industry and Food and Drug Administration Staff Introduction This draft guidance document provides recommendations that may help manufacturers comply with the special...
June 17, 2022
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,...
June 16, 2022
Guidance Document Draft Guidance for Industry June 2022 This guidance describes a standards recognition program for regenerative medicine therapies (SRP-RMT) at FDA’s Center for Biologics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...
June 15, 2022
Guidance Document June 2022 This draft guidance, when finalized, will represent the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any...
June 10, 2022
The final version of ICH M10 “Bioanalytical Method Validation and Study Sample Analysis” was adopted on May 24, 2022. This is the harmonized guideline which has been ratified by participating...
June 8, 2022
Today, FDA published a new Manual of Policies and Procedures (MAPP), “Assessment of the User Interface of a Drug-Device Combination Product Submitted in a Pre-ANDA Communication or an ANDA (5223.6).”...
June 8, 2022
FDA recently added a search function to the National Drug Code (NDC) Directory webpage for human drugs compounded by outsourcing facilities that assign NDC numbers to their products. This update was...
June 7, 2022
Guidance Document June 2022 This guidance document provides the FDA’s recommendations on testing to assess the electromagnetic compatibility of medical devices and information to include in the...
