FDA's drug regulatory pathways, its development strategies and regulatory considerations

People who are interested in drug development may be aware that New Drug Applications (NDA) and Abbreviated New Drug Applications (ANDA) are 2 of the FDA's regulatory pathways for how prescription drugs can be approved and ultimately reach the market. In basic terms, NDAs are for new drugs that have not yet been approved and ANDAs are for generic products. NDA, also called 505 (b)(1), is the format that manufacturers use to bring a formal proposal to the FDA that a new drug should be approved and made available for use by patients in the United States. Under 505(b)(1), all investigations supporting safety and effectiveness, both clinical and nonclinical, are conducted by or on behalf of the sponsor. The other pathway is termed as abbreviated because preclinical and clinical trials are not required. The abbreviated approval pathways are described in section 505(j) and 505(b)(2) of the FD&C Act and known as ANDA and Hybrid applications respectively. Hatch-Waxman amendments in 1984 provided for a suitability petition that allows the application of ANDA for a drug product that differs from the RLD in its dosage form, route of administration, strength, or active ingredient (in a product with more than one active ingredient). The differences allowed for suitability petition and 505(b)(2) application are same but ANDA filed through suitability petition can contain only those differences that do not need clinical evidence for efficacy and safety. This article identifies considerations to help potential applicants determine the appropriate submission pathway, its development strategies to support approval under those pathways.

Regulatory compliances in development of commercial scale process of Nanoparticles (Liposomes and Niosomes) in pharmaceutical industry : A review

The main objective of this review work was designed to explore the regulatory environments that govern the pharmaceutical industry. Main objective of regulatory department is to maintain the quality, safety and efficacy of the medical products it also ensures the standard of medicinal product for sales, importing and manufacturing. The biggest challenge faced by the pharma manufactures is Scaling up their production. Our review process focuses on regulatory requirements concerning Liposomes and Niosomes and their limitations in respect to industrial applicability. In detail explanation of what type of information should be submitted to FDA and EU in new drug applications (NDAs) or abbreviated new drug applications (ANDAs). By comparing these two developed regulatory markets we can build a strong regulation in Indian market on Liposomes and Niosomes. The review study deals with the sound knowledge about regulatory landscape that governs the pharmaceutical industry. Study describes in depth about liposomes and niosomes delivery systems and gives a critical overview of the current regulatory landscape surrounding commercialization efforts of higher-level complexity systems, the expected requirements and the hurdles faced by companies seeking to bring novel liposome and noisome based systems for clinical use to market.

Secondary patents: innovator and generic strategies

The global pharmaceutical industry consists of innovators and generics. Innovators focus on drug discovery, and bring new drugs into the marketplace after filing the new drug applications. In contrast, the generics enter the market by making a bioequivalent product by filing abbreviated new drug applications. In order to maximize their returns on R&D and maintain market share, the innovators introduce a wide range of drug products based on the same ‘new molecular entity’ and protect them against competition by filing what the industry term as secondary patents. The patents of four innovator viz., AstraZeneca, Takeda, Eisai and Wyeth related to the gastroesophageal reflux disease drugs and how their new molecular entity patents overcame the nonobviousness criteria is analyzed and studied in detail.