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?
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.
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Drug Discovery World
FEBRUARY 12, 2024
In the upcoming year, we will see the expansion of new, more complex markets and updated requirements from regulators. The challenge is harnessing the power of AI within a highly regulated industry. Fiona Maini, Senior Director Global Compliance and Strategy at Medidata “AI is dominating conversations across the drug discovery process.
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.
Cloudbyz
AUGUST 9, 2023
As it becomes more complex with growing volumes of data, evolving regulations, and the pressure for faster drug development, traditional methods of clinical research management are no longer sufficient. Integrated Compliance and Governance With stringent regulations governing clinical trials, compliance is of utmost importance.
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.
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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