scholarly journals INSIDE STORY FOR REVIEW OF AN ABBREVIATED NEW DRUG APPLICATION

2018 ◽  
Vol 2 (1) ◽  
pp. 29-31
Author(s):  
Rajkumar Gupta
Keyword(s):  
Generic Drugs ◽  
Drug Application ◽  
Data Integrity ◽  
Marketing Authorization ◽  
Electronic Submission ◽  
New Drug ◽  
Patent Rights ◽  
New Drug Application

ANDA constitutes an important submission for marketing authorization of generic drugs. The FDA has recently mandated an electronic submission in the form of eCTD for the same. ANDA application is quite complex with respect to patent rights and BE evaluations. The incomplete applications are often refused to file and the accepted applications some time get disqualified due to technical deficiencies at the manufacturing site. Recently FDA has rejected many ANDA applications in ASEAN region on account of data integrity.

Information Technology & FDA Compliance in the Pharmaceutical Industry

2011 ◽  
pp. 262-273
Author(s):  
Raymond Papp
Keyword(s):  
Information Technology ◽  
Pharmaceutical Industry ◽  
Food And Drug Administration ◽  
Drug Application ◽  
Over The Counter ◽  
Electronic Submission ◽  
Current Process ◽  
New Drug ◽  
Corporate Goals ◽  
New Drug Application

Given the recent profitability of and demand for pharmaceuticals, from prescription antibiotics and analgesics like Ciproflaxin and OxyContin and mens health drugs such as Viagra and Vardenafil to over-the-counter Senokot laxatives and Betadine antiseptics, the rush to develop and market new pharmaceuticals has never been greater. The current process is complex and it often takes several years for a drug to reach the market due to the myriad of Food and Drug Administration (FDA) guidelines. Furthermore, the recent FDA guidelines mandating that all New Drug Applications (NDA) be submitted in electronic (paperless) format by the end of 2002 is a catalyst for change in the pharmaceutical industry (FDA Proposes First Requirement for Electronic Submission, 2002; New Drug Application (NDA), 2001). Bayer Pharmaceutical, like its competitors Purdue Pharma and Boots Healthcare, has begun to take steps to assure that its use of information technology will allow it to not only meet FDA guidelines, but achieve its corporate goals of improved efficiency and reduced operating costs.

Information Technology & FDA Compliance in the Pharmaceutical Industry

2011 ◽  
pp. 280-291
Author(s):  
Raymond Papp
Keyword(s):  
Information Technology ◽  
Pharmaceutical Industry ◽  
Food And Drug Administration ◽  
Drug Application ◽  
Over The Counter ◽  
Electronic Submission ◽  
Current Process ◽  
New Drug ◽  
Corporate Goals ◽  
New Drug Application

Given the recent profitability of and demand for pharmaceuticals, from prescription antibiotics and analgesics like Ciproflaxin™ and OxyContin™ and men’s health drugs such as Viagra™ and Vardenafil™ to over-the-counter Senokot™ laxatives and Betadine™ antiseptics, the rush to develop and market new pharmaceuticals has never been greater. The current process is complex and it often takes several years for a drugto reach the market due to the myriad of Food and Drug Administration (FDA) guidelines. Furthermore, the recent FDA guidelines mandating that all New Drug Applications (NDA) be submitted in electronic (paperless) format by the end of 2002is a catalyst for change in the pharmaceutical industry (FDA proposes first requirement for electronic submission, 2002; New Drug Application [NDA], 2001). Bayer Pharmaceutical, like its competitors Purdue Pharma and Boots Healthcare, has begun to take steps to assure that its use of information technology will allow it to not only meet FDA guidelines, but achieve its corporate goals of improved efficiency and reduced operating costs.

Utility of Bayesian Single-Arm Design in New Drug Application for Rare Cancers in Japan: A Case Study of Phase 2 Trial for Sarcoma

2018 ◽  
Vol 52 (3) ◽  
pp. 334-338 ◽  
Author(s):  
Akihiro Hirakawa ◽  
Tadaaki Nishikawa ◽  
Kan Yonemori ◽  
Taro Shibata ◽  
Kenichi Nakamura ◽  
...  
Keyword(s):  
Drug Application ◽  
Phase 2 ◽  
Rare Cancers ◽  
New Drug ◽  
Phase 2 Trial ◽  
New Drug Application

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 COMPARISON OF GLOBAL REGULATORY GUIDELINES FOR AVAILABILITY OF DIFFERENT BIOWAIVER PROVISIONS AND APPLICATION REQUIREMENTS OF BIOPHARMACEUTICS CLASSIFICATION SYSTEM (BCS) BASED BIOWAIVER.

2018 ◽  
Vol 3 (3) ◽  
pp. 8-20
Author(s):  
Jimi Patel ◽  
Priti Mehta ◽  
Vaishali Kothari
Keyword(s):  
Development Strategy ◽  
Classification System ◽  
Drug Application ◽  
Biopharmaceutics Classification System ◽  
New Drug ◽  
Novel Approach ◽  
Permeability Study ◽  
New Drug Application ◽  
Biopharmaceutics Classification

To waive a complete and systemic Bioequivalence (BE) study, Biowaiver or Request for a Biowaiver is a fast track approach to boost the drug development process. Over the past three-four years the Biowaiver market shows greater number of Biowaiver submissions and the wider use of In-vitro permeability study. Biowaiver is a beneficial approach for getting approval of Abbreviated New Drug Application (ANDA) while, BCS based Biowaiver is the novel approach to gain approval for New Drug Application (NDA) as well as ANDA. A Biopharmaceutics Classification System (BCS) based Biowaiver is an exemption from conducting human bioequivalence studies when active ingredient and dosage form meet criteria of solubility, permeability and dissolution. The Paper covers different kind of Biowaiver approaches and the criteria for the applicability of BCS based Biowaivers in the different geographic scopes with regard to global development strategy. There is a comparison of global guidelines on provisions availability for different types of Biowaiver approaches as well as for requirements of Biowaiver based on BCS. From comparison of different global guidelines it is reviewed that most of the guidance resembles to the USFDA, EU and WHO guidelines because most of the regulatory authorities are following the BCS based Biowaiver concept as one of the three main guidance documents (USFDA, EMA, WHO) or a combination of specific requirements.

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