ProRelix Research
DECEMBER 28, 2023
Considering the crucial role that the information generated from clinical trials play in the approval of new drugs, biological, and medical devices, it is only logical that the data garnered […] The post Clinical Data Standardization in Clinical Trials: FDA Compliance in Clinical Data Management appeared first on ProRelix Research.
Pharma Mirror
JANUARY 5, 2024
Spearheaded by a former US FDA Investigator and seasoned pharmaceutical executive, FD-AID is uniquely positioned to bring a wealth of expertise and insight to India’s rapidly growing pharmaceutical industry.
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XTalks
DECEMBER 9, 2024
The US Food and Drug Administration (FDA) has released a new draft guidance titled Expedited Program for Serious Conditions Accelerated Approval of Drugs and Biologics Guidance for Industry refining the accelerated approval pathway for drugs and biologics targeting serious or life-threatening conditions.
FDA Law Blog
JANUARY 1, 2024
Maybe that’s also why FDA last week publicized the highest number of important Warning Letters of the year (compared with prior releases in 2023). Perhaps FDA wanted us to remember 2023 as the year FDA succeeded in uncovering critical defects in drug and device manufacturing, and in critical trials.
Pharma Marketing Network
OCTOBER 24, 2024
New drugs, evolving technologies, and emerging marketing channels are creating fresh opportunities for pharma marketing executives. From targeted cancer therapies to specific drugs for chronic illnesses, pharma companies must market treatments that speak to individual patient needs. The trick is balancing engagement with compliance.
Cloudbyz
AUGUST 19, 2024
Food and Drug Administration (FDA), the European Medicines Agency (EMA), and various other national and international organizations oversee the approval, monitoring, and post-market surveillance of medical devices. Food and Drug Administration (FDA): Oversees the safety and effectiveness of medical devices in the United States.
FDA Law Blog
JUNE 9, 2021
Koblitz — While typically, FDA is responsible for setting forth its own agenda and enforcing compliance with its own regulations, the Trump Administration’s HHS, on its way out the door in late 2020 , took the unusual steps of withdrawing an important FDA Compliance Policy Guide, “Marketed Unapproved Drugs – Compliance Policy Guide Sec.
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