REVIEW ON SPONSOR / APPLICANT MEETINGS WITH FDA: HIGHLIGHTS OF NEW GUIDANCE OVER EXISTING
Journal Title: International Journal of Drug Regulatory Affairs - Year 2016, Vol 4, Issue 2
Abstract
The United States Department of Health and Human Services has a federal agency called the Food and Drug Administration (FDA or USFDA). A pre-planned assembling of two or more people who have been together for the purpose of getting a common goal via verbal interaction is called a formal meeting. During development stage of any drug or biological products pharmaceutical companies face trouble for both scientific and regulatory point of view, here role of formal meetings comes. Formal meetings between sponsor or applicant and FDA are usually related to development and review of drug and biological products. Center for Drug evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) regulates the formal meetings. These meetings are applicable to Pre – Investigational New Drug Application, Pre – Biologics License Application, New Drug Application for drugs and biological products and not applicable to Abbreviated New Drug Applications (ANDA), application of medical devices and submission of biosimilar biological products. Meetings between FDA and sponsor or applicant are for resolution of dispute, clinical holds discussion, Assessment of protocols of clinical trial, during clinical trials, in between clinical trials – at the phase 1 ending or at the phase 2 ending, to discuss development program. The FDA has classified these formal meetings in different types based on the nature of the request, the information in the meeting request and each meeting type is handled through different procedures. The principles of Good Meeting Management Practices (GMMPs) must be maintained. There are specific requirements and procedures to request, prepare, schedule, conduct and document formal meetings. As the guidance documents for meetings are revised by FDA, Change in procedure and requirements takes place. Any pharmaceutical company need to be in line with new guidance requirements to avoid rejection. Formal meetings between sponsor or applicant and FDA save time, cost and will increase the probability of product approval.
Authors and Affiliations
Kothari Charmy, Shah Kavina
Keywords
Related Articles
- EP ID EP338086
- DOI -
- Views 82
- Downloads 0
A SNAP-SHOT OF FIRST-LINE ART TREATMENT FAILURE CASES FROM MPUMALANGA PROVINCE ON THE DECENTRALISED PHARMACOVIGILANCE PROGRAMME DATABASE
The increase in ART use comes with the inevitable increase in cases of ART treatment failure, especially that patients are living longer on ART. The main objective of this short study was to conduct an interim review of...
FORMULATION AND DEVELOPMENT OF KETOPROFEN BILAYER TABLETS
Aim of present research work was formulation and development of bilayer tablets of Ketoprofen to reduce the side effects of Ketoprofen and to improve the therapeutic benefits and patients’ compliance to treatment. Bi-lay...
ACTD: BRIDGE BETWEEN REGULATORY REQUIREMENTS OF DEVELOPED AND DEVELOPING COUNTRIES
Regulatory Dossier contains data which when submitted to the regulatory authority, provides for the review and ultimate approval of a drug product. Once approved, an applicant may manufacture and market the drug to provi...
A comprehensive study of Regulatory compliance for Biosimilars in US, EU and India
The biopharmaceutical industry has gained significant interest in the last decade as the numbers of blockbuster biologic products are losing their patent rights. The regulatory authority is also providing marketing appro...
LYOPHILIZATION - PROCESS AND OPTIMIZATION FOR PHARMACEUTICALS
In this 21st century, Lyophilization emerges to be a novel trend for the drying of pharmaceuticals and biological that are thermolabile or are unstable in aqueous form but stable for longer periods in their dried form. T...