FDA NME & NCE

FDA NME & NCE

Start Up, New Molecular Entities (NME) and New Chemical Entities (NCE) are high quality, affordable products that improve the quality of life for their patients. However, this often is associated with austere conditions wherein time and funds are both in short supply. Effective and consistent compilation of NME & NCE Product and Process Development for…

FDA CDER & CBER Global Data Standards

FDA CDER & CBER Global Data Standards

Start Up and Generic Pharmaceutical Drug and Biologic Companies have high quality, affordable products and biosimilars that improve the quality of life for their patients. However, this often is associated with austere conditions wherein time and funds are both in short supply. Effective and consistent use and application of Data Standards can reduce costs of…

Visible Particles within Injectable Products

Visible Particles within Injectable Products

The FDA expects and requires that Sterile Injectable Products adhere to strict FDA standards pertaining to quality, purity, safety, and efficacy. As a result, Patients and Physicians rely upon and trust that the Injectable Products they administer adhere to the same high standards. The cGMP Injectable Product Manufacturing process is generally the primary place where…

combination of drug product development

Facts About Combination Drug Products and Their Developments

Introduction: The diagnostic products, including drugs, devices, and biological products, are commonly referred to as Combination drug products. Combination products generally contain components that are typically regulated by different types of regulatory authorities. These products also face different kinds of challenges by various FDA centers regarding regulation, policy, and review management. The regulatory processes can…

AB Rating 505b2 NDA Generic

FDA Grants AB Rating to 505b2 NDA Generic

FDA recently granted a therapeutic equivalence (TE) rating of AB to a “generic” version of an innovator product approved via a 505b2 NDA.  In July 2014, FDA granted the AB rating to Perrigo’s 1% testosterone gel drug product (NDA 203098) approved in January 2013, and a BX rating to Teva’s (NDA 202763) approved in February 2012. …

As Expected, User Fee Bill Passes House Heads for Senate

The Food and Drug Administration Safety and Innovation Act (FDASIA) goes to the Senate for a vote next week after passing by a large margin in the House June 20. The new user fee legislation will result in a number of changes at FDA including generic user fees.  At the current pace, signature into law…

Transcript for FDA’s Rx to OTC Meeting

As was previously promised, here are the transcripts (1 2) from FDA’s meeting entitled “Utilizing Innovative Technologies and Other Conditions of Safe Use To Expand Access to Nonprescription Drugs.” Contact us to find out how our experience can help your company expand your line of prescription and OTC products.

FDA Risk Evaluation Workshop Announced

The Food and Drug Administration (FDA) announced a public workshop entitled “Risk Evaluation and Mitigation Strategy Assessments: Social Science Methodologies to Assess Goals Related to Knowledge.” The purpose of the public workshop is to initiate constructive dialogue and information-sharing among regulators, researchers, the pharmaceutical industry, health care organizations, health care providers, and others from the…