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FDA regulatory 510(k) – Page 2 – globalcompliancepaneltraining
Category Archives: FDA regulatory 510(k)
As the primary regulator of the biological, healthcare, life sciences and other related industries; the FDA has power and authority over how its work is carried out. FDA Warning Letters are among the primary mediums through which it enforces its authority. The FDA issues a Warning Letter to a company when it determines, following its […]
Posted byGlobalCompliancePanel-Training January 3, 2018 January 3, 2018 Posted inA Tour of the FDA, fda, FDA 21 CFR Part 11 Compliance, fda audit, FDA Compliance, FDA organized, FDA regulatory 510(k), FDA Submissions, history of the FDA, New FDA FSMA Rules, UncategorizedTags: Compliance and Regulatory Information, Compliance Best Practices, fda regulations, fda regulatory compliance, FDA Regulatory Compliance Practices, Regulatory and FDA compliance, regulatory compliance, US FDA Regulatory Requirements3 Comments on FDA Warning Letters – an understanding
Import rules are very rigid and strict in the US, because products of any type and variety can enter the US. The US being the world’s largest consumer economy; manufacturers and marketers from around the world vie for a chunk of this market. The FDA, being the agency that regulates a myriad of products, has […]
Posted byGlobalCompliancePanel-Training December 14, 2017 December 14, 2017 Posted inA Tour of the FDA, fda, FDA 21 CFR Part 11 Compliance, fda audit, FDA Compliance, FDA organized, FDA regulatory 510(k), FDA Submissions, history of the FDA, New FDA FSMA Rules, UncategorizedTags: FDA IMPORT and EXPORT COMPLIANCE, FDA Import for Export Requirements, FDA Import Form, FDA Import Program, Importing FDA Regulated Products into US, Tougher import rules for FDA, US FDA RegulationsLeave a comment on Tougher FDA import rules are aimed at putting strict controls on imports
The FDA has set out requirements for sponsors and organizations that carry out clinical trial to ensure premarketing clinical trial safety. This is a very vital requirement because this is the stage at which the database that goes into clinical trials is formed. Its integrity and safety is an important ingredient for assessing the risks […]
Posted byGlobalCompliancePanel-Training December 12, 2017 Posted inA Tour of the FDA, fda, FDA 21 CFR Part 11 Compliance, fda audit, FDA Compliance, FDA organized, FDA regulatory 510(k), FDA Submissions, history of the FDA, New FDA FSMA Rules, UncategorizedTags: best practices, design, Differences between clinical trials and post marketing, education, finance, HEALTHCARE, management, Medical, Post-marketing monitoring, Pre-marketing clinical trials, Premarketing Clinical Evaluation, Premarketing Clinical Trial Safety, Premarketing Risk Assessment, Project Management, Running, techniques, trainingLeave a comment on FDA Requirements for ensuring Premarketing Clinical Trial Safety
The FDA grants marketing approval for certain types of medical products whose application is the result of foreign clinical studies, provided the products and the clinical studies meet certain conditions. The types of medical products that are permitted under this system of foreign clinical studies include: A human drug A biological drug A medical device […]
Posted byGlobalCompliancePanel-Training December 11, 2017 Posted inA Tour of the FDA, fda, FDA 21 CFR Part 11 Compliance, fda audit, FDA Compliance, FDA organized, FDA regulatory 510(k), FDA Submissions, history of the FDA, New FDA FSMA Rules, UncategorizedTags: Acceptance of Foreign Clinical Data, best practices, design, education, fda acceptance of foreign clinical trial data, fda guidance acceptance of foreign clinical studies, Foreign Clinical Studies, Foreign Clinical Studies for US Approval, foreign clinical studies requirements, HEALTHCARE, Medical, medicine, Project Management, Running, techniques, trainingLeave a comment on The FDA’s requirements for non-IND Foreign Clinical Studies
The IND is a process which gives the sponsor the opportunity to start marketing across the States of the US without having to complete the formal process. it also gives the patient the assurance that the drug that is being administered may not have gone through the full regulatory process as yet, but is as […]
Posted byGlobalCompliancePanel-Training December 8, 2017 Posted inA Tour of the FDA, fda, FDA 21 CFR Part 11 Compliance, fda audit, FDA Compliance, FDA organized, FDA regulatory 510(k), FDA Submissions, history of the FDA, MEDICAL DEVICE, medical device reporting and recalls, medical devices, Medical Devices Training, Medical Professionals, New FDA FSMA Rules, UncategorizedTags: Investigational New Drug Applications in the USA, New Drug Application Checklist in USA, New Drug Application Process USA, Risks in new drug development, Understanding FDA Regulatory Requirements, US new drug applicationsLeave a comment on The Investigational New Drug Applications mechanism in the USA
Posted byGlobalCompliancePanel-Training November 29, 2017 November 29, 2017 Posted in10 Best States for Health Care, A Tour of the FDA, fda, FDA 21 CFR Part 11 Compliance, fda audit, FDA Compliance, FDA organized, FDA regulatory 510(k), FDA Submissions, Food and Drug Administration, food safety, Health, Health & Environment Management System, health care, HEALTHCARE, history of the FDA, Mental health, New FDA FSMA Rules, UncategorizedTags: Compliance and Enforcement Strategy for Food, Compliance with Food Safety Regulations, education, Food Business Inspections, food safety, Food Safety Compliance, Food Safety Modernization Act, Food Safety Practices, Global Food Safety Compliance, HEALTHCARE, Medical, Project Management, quality and compliance management, techniques, training1 Comment on What is logistics and supply chain management?
The adverse event reporting system is an important highlight of the FDA’s adverse event reporting requirements. This is the mechanism through which adverse event reporting requirements are listed out for the FDA to take further action. The adverse event reporting system may be understood as being a database that aids and supplements the FDA’s postmarketing […]
Posted byGlobalCompliancePanel-Training November 28, 2017 November 28, 2017 Posted inA Tour of the FDA, fda, FDA 21 CFR Part 11 Compliance, fda audit, FDA Compliance, FDA organized, FDA regulatory 510(k), FDA Submissions, history of the FDA, New FDA FSMA Rules, UncategorizedTags: Adverse Event Reporting Regulations, Adverse Event Reporting System, conference, design, education, FDA SAE Reporting Requirements, fda software guidance, fda software validation, fda software validation guidance, FDAs new reporting regulations, Medical, medical device software, medical device software testing, regulatory compliance software, seminar, techniques, The FDAs Adverse Event Reporting Requirements, trainingLeave a comment on The FDA’s Adverse Event Reporting Requirements
Registering and maintaining combination products in the US and the EU is a bit tricky, because these are disparate markets that are governed by different sets of regulations which are independent of each other. So, any business that wants to market combination products into the US or the EU must be completely aware of the […]
Posted byGlobalCompliancePanel-Training November 17, 2017 Posted inCosmetics Product Regulation, FDA regulatory 510(k), Regulatory and Compliance, regulatory approval, regulatory industry, UncategorizedTags: design, Drug Device Combination Products Regulations, Drugs Seminar, education, finance, HEALTHCARE, heart, management, Medical, medicine, Project Management, Regulatory Affairs, Running, techniques, training1 Comment on Regulations in the US and EU Dealing with Combination Products
Philadelphia woman tries passing fake scripts at Palmer pharmacy
PALMER TWP., Pa. – A Philadelphia woman is facing fraud charges after she allegedly arrived at a Northampton County pharmacy Wednesday night with fake prescriptions for more than 200 pills. Police arrested Samantha M. Brown at a Palmer Township Rite Aid with fraudulent prescriptions for Oxycodone, Alprazolam and Flexiril. The 25-year-old now faces three felony […]
Posted byGlobalCompliancePanel-Training November 10, 2017 Posted inA Tour of the FDA, fda, FDA 21 CFR Part 11 Compliance, fda audit, FDA Compliance, FDA organized, FDA regulatory 510(k), FDA Submissions, history of the FDA, New FDA FSMA Rules, UncategorizedLeave a comment on Philadelphia woman tries passing fake scripts at Palmer pharmacy
A phase 3 trial studying the effects of tolvaptan has found that the drug slowed the rate of decline in kidney function in patients with polycystic kidney disease… A phase 3 trial studying the effects of tolvaptan has found that the drug slowed the rate of decline in kidney function in patients with the most […]
Posted byGlobalCompliancePanel-Training November 9, 2017 November 9, 2017 Posted inA Tour of the FDA, fda, FDA 21 CFR Part 11 Compliance, fda audit, FDA Compliance, FDA organized, FDA regulatory 510(k), FDA Submissions, history of the FDA, New FDA FSMA Rules, PHARMA, pharmaceutical, Pharmaceutical Laboratories, pharmaceutical water systems, UncategorizedTags: best practices, education, FDA 21 CFR Part 11, fda regulation, HEALTHCARE, Medical, pharmaceutical, pharmaceutical companies, pharmaceutical industry, pharmaceutical manufacturers, Pharmaceuticals, Project Management, Running, techniques, trainingLeave a comment on Lonza news Tolvaptan identified as a treatment for autosomal dominant polycystic kidney disease