Bioanalytical Methods and Bioequivalence Studies Journal - SciDocPublishers
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These slides are based on, and expand upon, an article in the BMJ, available at http://www.bmj.com/content/347/bmj.f5992 .
Jake Williams - Navigating the FDA Recommendations on Medical Device Security...
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The document discusses the FDA's guidance on medical device cybersecurity. It outlines that the FDA's scope goes beyond HIPAA and includes risk analysis for devices and networks. Researchers identified vulnerabilities in 300 medical devices in 2013. The FDA issued a safety communication in 2013 calling for cybersecurity safeguards for devices and networks. A risk analysis model for devices includes privacy, availability, authentication, integrity, non-repudiation and safety factors. Manufacturers must now include cybersecurity risk analyses and protections in device design submissions to the FDA and disclose security features through an industry standard form. Intrusion detection aims to identify unauthorized access attempts and advanced persistent threats can be detected through Splunk monitoring of foreign access attempts.
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Abriviated new drug application
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3. Manufacturing and control requirements are important for ANDA approval. From 1977-1992, 105 applications were not approved due to issues in this area.
4. The Hatch-Waxman Act established 180 days of generic marketing exclusivity for the first ANDA applicant challenging a patent
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Bioavailability of drgs that follow nonlinear pharmacokinetics
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The document provides background information on the Hatch-Waxman Act, including:
- It summarizes the key people involved in creating the Act - Henry Waxman and Orrin Hatch.
- It outlines the history of drug regulation legislation leading up to the Hatch-Waxman Act of 1984.
- It describes the objectives and key features of the Hatch-Waxman Act, which established an abbreviated approval pathway for generic drugs to help increase competition and lower drug costs.
US FDA medical device approval chart - Emergo
Simple one page chart shows the US FDA medical device approval process for Class 1, 2 and 3 devices. Very easy to understand.
Cmc biologics pathway_draft8
Edward Narke discussed the CMC pathway for biologics through clinical development and market approval. The goals are to better understand FDA requirements, visualize a cost-effective approach to manage manufacturing processes, and appreciate challenges in controlling safety, potency, and impurities. Biologics have complex structures that must be characterized and controlled. Assay methods, product specifications, stability data, and comparability between clinical and commercial materials are common reasons INDs are placed on clinical hold. Managing impurities, developing relevant potency assays, and collecting data continuously are important strategies to address these challenges over the course of development.
Getting Your Medical Device FDA Approved
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regulatory requirement for bioequivalence
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The document summarizes the history and development of drug regulation laws in the United States from the early 1900s to present day. Key acts and amendments established safety testing requirements for drugs, created the FDA, and defined the modern drug approval process including preclinical research and multi-phase clinical trials. The modern system aims to balance drug accessibility while ensuring safety and efficacy through a rigorous review and oversight process from development through post-marketing.
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Bioavailability and bioequivalence – problems and pitfalls
PharmaCon2007 Congress, Dubrovnik, Croatia "New Technologies and Trends in Pharmacy, Pharmaceutical Industry and Education" http://www.pharmacon2007.com
Abstract is available at http://www.pharmaconnectme.com
Understanding FDA Requirements Medical Devices
The medical device market is experiencing explosive growth. Currently valued at $90 billion, market growth will continue to accelerate as demographics and market drivers increase their pressure for new and innovative product offerings.
Moreover, a substantial investment of time and resources is required to properly evaluate a new product idea and estimate its potential for success. So when a company executive declines a seemingly good product idea, what is probably being declined is the expense of properly evaluating the idea, and after having paid these expenses, the prospect of embarking on an expensive commercialization effort that has a 90 percent chance of failing.
Regulations for drug approval in USA, E.U & India
Regulations for drug approval in USA, E.U & India
Pharmaceutical industry is the most regulated of all the industries. Regulations are put in order to develop the most efficient and safe pharmaceutical products. It takes more than 8 to 15 years to develop a new drug product & costs more than $ 800 million.
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