The US Food and Drug Administration (FDA) has issued notices inviting subject-matter experts and consumer representatives to volunteer for its advisory committees. The move comes after the committees saw a diminished role under previous FDA leadership.
CHARLOTTE, NC — Officials from the US Food and Drug Administration (FDA), UK Medicines and Healthcare products Regulatory Agency (MHRA), and other European regulators said that successful meetings with sponsor involved transparency, open collaboration, listening, early communication, and having sufficient data to answer questions.
The US Food and Drug Administration (FDA) issued final guidance on 13 August regarding the types and timelines for formal meetings that sponsors can request during the development of new drugs and biological products.
Officials from the US Food and Drug Administration (FDA) and pharmaceutical industry representatives could not reach an agreement on the number of reference product exclusions (RPE) to make each year, and agreed to table the issue until another meeting, according to the minutes from a recent discussion on reauthorizing the Biosimilar User Fee Act (BsUFA).
The European Medicines Agency (EMA) has finalized updated guidance on the information required for the manufacture and control of active substances used in medicinal products, with a 1 September date of application.
Amid discussions to reauthorize the US Food and Drug Administration's (FDA) Prescription Drug User Fee Act (PDUFA VIII) program on 19 February, industry representatives questioned increased PDUFA payroll spending in FY 2025 – despite staff cuts that year – and both sides reached agreement on continuing the Rare Disease Endpoint (RDEA) program.
Officials from the US Food and Drug Administration (FDA) and representatives from the generic drug industry met on 19 February as part of the negotiations for the fourth iteration of the Generic Drug User Fee Amendments (GDUFA) program. The topics addressed during the meeting included drug master files (DMFs), internal consultations, and imminent actions.
Last month, the US Food and Drug Administration (FDA) and the pharmaceutical industry concluded a series of subgroup meetings toward the reauthorizing the Prescription Drug User Fee Program (PDUFA VII).
The European Medicines Agency's (EMA) Network Data Steering Group (NDSG) on Monday released a joint workplan outlining a strategy for leveraging artificial intelligence (AI) and big data over the next two years to expedite the approval of new medicines.
The medical device industry has expressed concerns about the US Food and Drug Administration's revised proposals for resource allocations and enrollment for the Total Product Lifecycle (TAP) program 2.0 program as part of the negotiations for the Medical Device User Fee Amendments VI (MDUFA). Industry also supported extending benefits beyond enrolled products.
