scholarly journals FDA relations during drug development

2000 ◽  
Vol 2 (3) ◽  
pp. 213-217
Keyword(s):  
Drug Development ◽  
Drug Application ◽  
Development Program ◽  
The United States ◽  
Legal Aspects ◽  
Development Programs ◽  
New Drug ◽  
Regulatory Affairs ◽  
New Drug Application ◽  
Drug Development Program

Working closely and cooperatively with regulatory authorities during drug development is vital to successful drug development programs. In the United States, the drug development team includes not only members of the key disciplines of drug discovery, clinical research, regulatory affairs, marketing, chemistry, toxicology, and legal aspects, but also the Food and Drug Administration (FDA). New regulations encourage meetings at the pre-investigational new drug (pre-IND), end-of-phase-2, and pre-new drug application (pre-NDA) submission phases. Appropriate informal discussions via fax and telephone are also encouraged. By proactively interacting with the FDA, the pharmaceutical industry increases the probability of a successful drug development program.

scholarly journals REVIEW ON SPONSOR / APPLICANT MEETINGS WITH FDA: HIGHLIGHTS OF NEW GUIDANCE OVER EXISTING

2018 ◽  
Vol 4 (2) ◽  
pp. 19-26
Author(s):  
Charmy Kothari ◽  
Kavina Shah
Keyword(s):  
Clinical Trials ◽  
Management Practices ◽  
Drug Application ◽  
Development Program ◽  
The United States ◽  
United States Department ◽  
Biological Products ◽  
New Drug ◽  
License Application ◽  
New Drug Application

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.

An Examination of the Drug Review Process Within the United States

1994 ◽  
Vol 13 (2) ◽  
pp. 121-142 ◽  
Author(s):  
Phillip A. Johns
Keyword(s):  
Drug Development ◽  
Development Time ◽  
Review Process ◽  
Drug Application ◽  
The United States ◽  
New Drugs ◽  
Total Drug ◽  
Scientific Approach ◽  
New Drug Application ◽  
Drug Review

A general overview of the drug review process is presented with emphasis on non-clinical approaches for gaining acceptable exemptions for investigational use of new drugs. Selected non-clinical requirements for approval of marketing or the new drug application are also discussed. Particular attention is given to the trend towards a more rational, scientific approach to the design of studies that are intended to elucidate issues of safety and efficacy. The fundamental purpose of these new approaches is to reduce drug development time and expense and bring newer and better drug therapies to patients. Newer requirements for the conduct and use of kinetics earlier in development are emphasized. The relevance of meetings with the Food and Drug Administration and the effects that meetings are reported to have had on total drug development time are also discussed.

Analyzing United States Prescribing Information to gain insight into FDA-sponsor discussions

1969 ◽  
Vol 17 (3) ◽  
Author(s):  
Iraj Daizadeh
Keyword(s):  
United States ◽  
Drug Development ◽  
Drug Application ◽  
The United States ◽  
Data Repository ◽  
Fda Approval ◽  
New Drug Application ◽  
Development Paradigm ◽  
Prescribing Information ◽  
Insight Into

The United States Prescribing Information (USPI) is a key vehicle for communicating the benefit-risk information of a Food and Drug Administration (FDA) approved prescription drug. The USPI is typically the last step of the drug development process and requires discourse between the FDA and the sponsor for a new drug application. The USPI may also be updated after obtaining FDA approval. As a social artifact of industry and FDA discussions, it is hypothesized that an analysis of a library of USPI records may yield insight into this dialog. Here, an analysis of DailyMed – a USPI data repository – reveals that structural language similarities (linguistic typologies) exist across USPI. Interestingly, these typologies describe labeling language that may not be explicitly described in FDA regulatory documentation. It is proposed that the methodology herein proposed may be leveraged to potentially facilitate USPI development and FDA dialogue (and therefore expedite the drug development paradigm). Several examples are used to showcase the approach. A discussion on limitations of the methodology and opportunities for development is also presented.

scholarly journals U.S. Food and Drug Administration’s Patient-Focused Drug Development Initiative: Experience with Integration of Patient-Experience Data in a New Drug Application for Esketamine Nasal Spray Plus a Newly Initiated Oral Antidepressant for Treatment-Resistant Depression

2021 ◽  
Author(s):  
Eva G. Katz ◽  
Pauline McNulty ◽  
Bennett Levitan ◽  
Patricia Treichler ◽  
Jadwiga Martynowicz ◽  
...  
Keyword(s):  
Drug Development ◽  
Nasal Spray ◽  
Patient Experience ◽  
Drug Application ◽  
Treatment Resistant Depression ◽  
Treatment Resistant ◽  
New Drug ◽  
Resistant Depression ◽  
New Drug Application ◽  
Patient Focused Drug Development

AbstractThe Patient-Focused Drug Development initiative of the U.S. Food and Drug Administration (FDA) aims to ensure that the patient experience of disease and treatment is an integral component of the drug development process. The 21st Century Cures Act and Prescription Drug User Fee Act (PDUFA) VI require the FDA to publicly report the type of patient-experience data reviewed in a new drug application (NDA) to inform regulatory decision-making. This report describes a recent approach adopted at Janssen of integrating patient-experience data into the NDA for esketamine (SPRAVATO®) nasal spray with a newly initiated oral antidepressant (esketamine + AD) for treatment-resistant depression. During the development of esketamine + AD, patient-experience data were collected using several patient-reported outcomes, including the Sheehan Disability Scale and 9-item Patient Health Questionnaire (PHQ-9). Additionally, a patient-preference study assessed the relative importance of benefits and harms that patients allocated to different attributes of treatment. Preferences were collected from patients enrolled in phase 3 esketamine trials and from an online panel of primarily ketamine-naive patients. Patient-experience data were integrated into the esketamine NDA, the FDA advisory committee meeting briefing document, and the Sponsor’s presentation. The FDA acknowledged reviewing the patient-experience data and determined that they supported esketamine + AD for treatment-resistant depression. This report highlights the importance of integrating patient-experience methods early in drug development, their impact on assessing patient-relevant benefits and risks, and how they can help improve clinical program design.

Drug Development 101: A Primer

2020 ◽  
Vol 39 (5) ◽  
pp. 379-396
Author(s):  
Lorrene A. Buckley ◽  
Ilona Bebenek ◽  
Paul D. Cornwell ◽  
Aimee Hodowanec ◽  
Eric C. Jensen ◽  
...  
Keyword(s):  
Drug Development ◽  
Drug Application ◽  
Safety Testing ◽  
New Drug ◽  
Phase Development ◽  
Introductory Overview ◽  
Candidate Drug ◽  
License Application ◽  
Regulatory Submissions ◽  
New Drug Application

Drug development is a term used to define the entire process of bringing a new drug or device to market. It is an integrated, multidisciplinary endeavor that includes drug discovery, chemistry and pharmacology, nonclinical safety testing, manufacturing, clinical trials, and regulatory submissions. This report summarizes presentations of a workshop entitled “Drug Development 101,” held at the 39th Annual Meeting of the American College of Toxicology in West Palm Beach, Florida. The workshop was designed to provide an introductory overview of drug development. Experienced scientists from industry and government provided overviews of each area, with a focus on safety assessment, and described some of the challenges that can arise. The role of chemistry and manufacturing was discussed in the context of early- and late-stage product development and approaches to assess, control, and limit impurities. The toxicologic assessment was emphasized in early-phase development, from the selection of a candidate drug through the determination of a first-in-human starting dose. Clinical trial development was discussed in the context of regulatory requirements and expectations. The final topic of issues and considerations in the review processes of different types of submissions to Food and Drug Administration included advice for best practices in authoring good Investigational New Drug and New Drug Application/Biologic License Application submissions and interacting effectively with regulatory reviewers.

Sign in / Sign up

Export Citation Format

Share Document