Compliance Genome Regulation 
Pharmaceutical Technology
JUNE 5, 2023
Right now, it’s compliance by checkbox, in a static way. Regulators need to work together with industry to certify hot patches to quickly fix vulnerabilities while maintaining pharmaceutical quality,” adds Fracchia. Pharmacies have also received EU General Data Protection Regulation (GDPR) fines for not being in compliance,” he adds.
XTalks
MARCH 1, 2024
In a pivotal move for the food industry, the US Food and Drug Administration (FDA) has unveiled industry guidance for genome edited foods derived from plants. This landmark guidance aims to demystify the FDA’s risk-based approach towards both genome edited foods and all new plant varieties. What is Genome Editing?
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XTalks
JULY 3, 2024
Genome Editing in Plants The FDA has also released guidance for foods derived from plants produced using genome editing. This guidance aims to address the regulatory framework and safety assessments for genome-edited plant foods, providing clarity for industry participants involved in developing these innovative products.
Camargo
NOVEMBER 11, 2020
Labeling regulations prohibit reminder ads for products with boxed warnings, which the FDA requires when a drug product has very serious risks. The generic drug must also have the same labeling as the RLD (except for differences permitted under the Agency regulations). Manager of Regulatory Compliance. Co-Authors: Jenny Fielder.
Advarra
AUGUST 8, 2024
Artificial intelligence (AI) has taken the world by storm – and regulators are paying attention. We also summarize the key information pharmaceutical companies and contract research organizations (CROs) need to know to prepare for compliance. These risks face fewer regulations but must meet certain standards to ensure ethical use.
FDA Law Blog
MARCH 3, 2024
The Act is intended to address national security concerns by prohibiting certain conduct by regulated industry. Biotechnology companies of concern include BGI (formerly Beijing Genomics Institute), MGI, Complete Genomics, WuXi Apptec, and any subsidiary, parent, affiliate, or successor of such entities.
pharmaphorum
JULY 4, 2022
And this is where modern technologies and data-driven medical informatics can really bridge the gaps in rare disease research,” said Dr Joanne Hackett, head of Genomic and Precision Medicine at IQVIA, during a recent pharmaphorum webinar. Navigating rare disease research and treatment.
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