USA – Industry groups: Expand FDA’s RTOR guidance to cell and gene therapies
Stakeholders commenting on the US Food and Drug Administration (FDA) draft guidance with recommendations for applicants submitting New Drug Applications (NDA) and Biologic License...
USA – FDA seek to harmonize human subject protections with revised Common Rule
The US Food and Drug Administration (FDA) on Tuesday issued two proposed rules aimed at harmonizing certain sections of the agency’s regulations on human...
USA – New FDA guidance offers ethical roadmap for including children in clinical trials
The US Food and Drug Administration (FDA) has issued draft guidance outlining a series of ethical considerations for conducting clinical trials that involve children.
The guidance,...
USA – Califf: FDA committed to boosting complex generic drug development
Robert Califf, commissioner of the US Food and Drug Administration (FDA), said the agency is looking at new ways to assess bioequivalence and increase...
USA – FDA issues final rule on ‘right to try’ reporting requirements
Drug firms that agree to supply investigational medicines under the Right to Try Act must submit an annual summary detailing each use to FDA under a...
USA – Combination products: FDA finalizes list of CGMP alternatives, streamlined mechanisms
The US Food and Drug Administration (FDA) has released a finalized list of alternatives and streamlined mechanisms for current good manufacturing practice (CGMP) of...
USA – FDA issues guidance documents on labeling drug identity, constituents
The US Food and Drug Administration (FDA) has issued two draft guidance documents aimed at improving the consistency of labeling for both over-the-counter (OTC)...
USA – FDA finalizes guidance on submitting RWD/RWE in application cover letters
To help better track submissions that include real-world data (RWD) and real-world evidence (RWE), the US Food and Drug Administration (FDA) is asking drug...
USA – Groups weigh in on FDA’s licensing rules for 3PLs and distributors
Supply chain trading partners expressed broad support for the US Food and Drug Administration’s (FDA) proposed rule on uniform licensing standards for wholesale distributors...
USA – Industry experts tout potential for master protocols in pediatric clinical trials
Using master protocols in pediatric clinical trials could speed the development of drugs for pediatric indications that already have development programs for adults, according...
