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Best Practices for Responding to a Medical Device FDA 483

WEBFederal Register 74 FR 40211 outlines the 15 day period that FDA waits for written responses to a 483. It says if a company submits a written response to the agency within …

Actived: 7 days ago

URL: https://redica.com/best-practices-for-responding-to-a-medical-device-fda-483/

Process Capability in Focus in FDA Device Inspections

WEBAt the April virtual FDA/Xavier MedCon conference, FDA Office of Regulatory Affairs (ORA) Office of Medical Device and Radiological Health Operations …

Category: Medical Go Health

PIC/S GMP Inspection Reliance Guidance Helps Global Agencies

WEBAt the 2020 ISPE Europe Annual Conference held virtually in September, Ireland Health Products Regulatory Authority (HPRA) Inspection Manager and …

Category: Health Go Health

The Current State of Smart Devices and Combination Products

WEB2020 saw FDA taking an increasing look at digital health, particularly cybersecurity of smart devices.Novel device approvals were also high.Redica Systems …

Category: Health Go Health

The Current State of Global GMP Inspections Redica Systems

WEBLast year, the COVID-19 pandemic required global regulatory agencies to reframe how they approach GMP inspections. Redica Systems Senior GMP Quality …

Category: Health Go Health

Regulatory Compliance Data & Intelligence Resources

WEBWhat different offices carry out its compliance and enforcement function? Health Canada’s Regulatory Operations and Enforcement Branch (ROEB) is responsible for oversight …

Category: Health Go Health

Five FDA Warning Letters Issued in Four Years for Fraudulent …

WEBJuly 14, 2022. Over a four-year period, FDA issued five warning letters to a physician and associated entities and organizations—one from CDER for marketing unapproved new …

Category: Health Go Health

Postmarket Medical Device Surveillance at CDRH: Part I

WEBIn 2018, CDRH reemphasized its dedication to postmarket surveillance and signal management in its Medical Device Safety Action Plan. As part of that plan …

Category: Medical Go Health

FDA 483 Database Redica Systems

WEBDesigned with a deep understanding of the life sciences compliance landscape, it goes beyond basic data retrieval and offers deeper intelligence. Redica Systems is also the …

Category: Health Go Health

CMC Challenges and Opportunities in Latin America

WEBOpportunities include the use of bundling or shared packages—for example, in Central America and the Caribbean—taking advantage of the same language in …

Category: Health Go Health

FDA Warning Letters Week of 1/12/2020: CMO Quality

WEBHealth Pharma USA LLC (Rahway, NJ) received a warning letter on Dec 18, 2019 based on the outcome of an inspection ending June 3, 2019. The FDA reminds …

Category: Health Go Health

An Inside Look at China’s Regulatory and Drug Approval Processes

WEBRecent Legislation And Developments. Cao explained that there are multiple layers making up China’s drug regulatory framework (Figure 1). At the apex is the …

Category: Health Go Health

FDA Combination Products Policy and Guidance Changes

WEBAt the Xavier Health Combination Products Summit held virtually in late October 2020, John “Barr” Weiner, Associate Director for Policy, Office of Combination …

Category: Health Go Health

J&T Health and Wellness LLC [Saint Petersburg / United States of

WEBPublish Date Document Type Title; October, 2023: FDA 483: J&T Health and Wellness LLC - Form 483, 2023-10-18: July, 2021: FDA 483: J&T Health and Wellness LLC - Form …

Category: Health Go Health

Getting Drugs Approved in Mexico, Argentina, Colombia, And Peru

WEBThe following article by Redica Systems Senior GMP Quality Expert Jerry Chapman contains insights for companies intending to market new drugs in four Latin …

Category: Health Go Health

An FDA Perspective on Decentralized Clinical Trials: Part I

WEBAt the Society of Quality Assurance 2022 Annual Meeting in Palm Springs, Calif., FDA Office of Regulatory Affairs Bioresearch Monitoring Division I Director Anne …

Category: Health Go Health

Post-Approval Change Management Protocol Pilot Aims to …

WEBIf the protocol must be changed completely, the process starts back with a new PACMP consultation.”. Depending on the changes made at Step 1, Step 2 will …

Category: Health Go Health

Safecor Health, LLC

WEBExperience Redica Systems’ NEW AI document analysis for 483 documents and observations Redica Systems customers can leverage the full Quality and …

Category: Health Go Health

How To Get Drug Products Approved In Asia-Pacific Markets

WEBThe Asia-Pacific (APAC) region is known to be a diverse area with respect to languages, religion, culture, and economics. It is also heterogeneous with respect to …

Category: Health Go Health

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