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...
Topical Drug Products for Cutaneous Application: Human Safety Assessment Guidance

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The US Food and Drug Administration (FDA) has issued two draft guidance documents aimed at improving the consistency of labeling for both over-the-counter (OTC)...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...

USA – FDA issues emergency guidance to spur development of monkeypox tests

The US Food and Drug Administration (FDA) issued an immediately effective guidance and a corresponding FAQ to spur the development of new monkeypox diagnostics...

USA – FDA drafts guidance on pediatric clinical pharmacology studies

The US Food and Drug Administration (FDA) has laid out its thinking on the ethical and physiological issues sponsors should consider when planning to...

USA – Pharma groups: FDA is exceeding its authority in risk management plan guidance

The US Food and Drug Administration’s (FDA) draft guidance on risk management plans (RMPs) has overstepped the agency’s statutory bounds in requiring manufacturers of...

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