Vial

FEBRUARY 29, 2024

Contract research organizations (CROs) are an integral partner of the drug development process, as they play a pivotal role supporting clinical trial conduct for pharmaceutical, biotechnology, and medical device sponsor companies. billion, projected to grow at a compound annual growth rate (CAGR) of 6.9% between 2023 and 2032.

Clinical Trials 52

Clinical Trials Trials Clinical Research Drug Development 52

Perficient: Drug Development

AUGUST 12, 2023

This is what everyone is talking about in the market, and I couldn’t be more excited to learn not just about Salesforce AI capabilities, but how we can understand and trust AI more effectively. The AI market is projected to reach $407B by 2027, which is substantial growth from its $86.9B in revenue in 2022.

Marketing 52

Marketing 52

Agency IQ

MAY 17, 2024

How have pre-submission meetings for generic drug applicants changed under GDUFA III? Under GDUFA III, the scope and purpose of pre-submission meetings for generic drug developers has changed. The generic drug user fee program is currently on its third iteration (i.e.,

Science 40

Science FDA Drugs Production 40

Agency IQ

NOVEMBER 3, 2023

The agency further proposed a five “stage” phaseout of its current enforcement discretion, which would walk in the medical device regulatory requirements – from adverse events reporting to pre-market review – over four years. Under the proposed rule, these tests would be able to continue operating under the current status quo.

FDA 40

FDA Laboratories Regulations Production 40

Agency IQ

FEBRUARY 15, 2024

If you’re looking for something specific, we recommend using the search function in your browser (Ctrl-F) to look for keywords of interest. Priority A List.

FDA 40

FDA Science Biosimilars Clinical Trials 40

Agency IQ

FEBRUARY 2, 2024

This means that the medical device frameworks – including the pre-market pathways and evidentiary requirements, as well as post-market quality system frameworks and reporting requirements – are applied to the vast majority of all (CDRH-regulated) IVD products. IVDs used in blood donation screening/processing). In the E.U.,

FDA 40

FDA Laboratories Regulations Production 40

Agency IQ

JULY 28, 2023

On March 27, the FDA finalized a transition guidance document covering products that had been marketed under enforcement discretion policies during the PHE. Those concerns have proven serious enough that in September 2020 the FDA published a final guidance document calling on manufacturers of drug products to take two steps.

FDA 40

FDA Science Biosimilars Regulations 40