FDA accepts resubmission of New Drug Application for olanzapine/samidorphan

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.

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

International Journal of Drug Regulatory Affairs ◽

10.22270/ijdra.v3i3.167 ◽

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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INSIDE STORY FOR REVIEW OF AN ABBREVIATED NEW DRUG APPLICATION

International Journal of Drug Regulatory Affairs ◽

10.22270/ijdra.v2i1.122 ◽

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.

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