Agency IQ

JUNE 28, 2024

New guidance provides definition for orphan device, offers alternative trial designs New guidance from the European Commission outlines alternatives for full pre-market clinical trials for orphan devices, defined by the Commission for the first time. The need to document how and why a device qualifies as an orphan device (section 4.2)

Trials 40

Trials Marketing Clinical Trials Regulations 40

Agency IQ

JUNE 7, 2024

The PPPR framework governs the authorization, sale, and use of PPPs, establishing a pre-market approval process for active substances – the pesticide components which control pests, weeds, and plant diseases – and for synergists and safeners before they can be allowed for use in PPPs.

Regulations 40

Regulations Animal Testing Production Marketing 40

Agency IQ

MARCH 7, 2024

BY LAURA DIANGELO, MPH | MAR 6, 2024 5:54 PM CST Fiscal year 2024 appropriations bills On March 3, 2024, House and Senate appropriators released a package of final fiscal year (FY) 2024 appropriations bills. billion in “definite user fees.” AgencyIQ has the highlights. The total budget of ~$6.7 billion includes ~$3.5

FDA 40

FDA Packaging Science Drugs 40

Agency IQ

JULY 12, 2024

Proposed Rule Rulemaking to Provide by Regulation that an Ingredient Is Not Excluded From the Dietary Supplement Definition December 2024 This proposed rule, if finalized, would allow a specific ingredient to be marketed in or as a dietary supplement. It’s also interesting to see what isn’t on this list.

Regulations 40

Regulations FDA Science Production 40