Agency IQ

JULY 22, 2024

Updated EUDAMED roadmap projects mandatory use of some processes as early as December 2025 The new EUDAMED roadmap includes updates accounting for the recent amendments to the European medical device and diagnostics regulations, which allow for a phased rollout of the different functional modules of the database.

Regulations 40

Regulations Marketing Clinical Trials Trials 40

Alta Sciences

MARCH 8, 2024

billion by 2029. Manufacturing these drug products involves expert specialization and careful consideration to ensure that GMP regulations for drug submissions are met, the risk of exposure for CDMO-related personnel is reduced, and every effort is made to prevent cross-contamination.

Compliance 52

Compliance Engineering Regulations Drug Development 52

Agency IQ

JANUARY 26, 2024

regulators considered the highest-risk IVD devices, and these and devices for self-test by the patient required Notified Body oversight. The IVDR originally gave stakeholders 5 years to comply with the regulation (May 26, 2022). The directive used a list-based system – List A and List B outlined what E.U. Once the E.U.

Regulations 40

Regulations Compliance Laboratories Production 40

FDA Law Blog: Biosimilars

DECEMBER 3, 2023

Each phase-in policy allows eligible manufacturers to build up in a stepwise manner to the 10% and 20% applicable discounts by 2029 and 2031, respectively. CMS also intends to implement a compliance monitoring program through future regulations or guidance. had Part D expenditures on or before August 16, 2022).

Compliance 105

Compliance Drugs Pharmacy Licensing 105

Agency IQ

NOVEMBER 27, 2023

Its latest report serves as a powerful indicator for what EU chemical regulation is likely to resemble in the coming years should the agency receive sufficient scientific support to meet four regulatory challenges ECHA just can’t solve without further progress from the scientific community.

Animal Testing 40

Animal Testing Research Regulations Compliance 40

Agency IQ

MAY 10, 2024

By 2029, this will include artificial turf as well as outdoor apparel for severe weather conditions (unless it is accompanied by a specific warning statement). States like Alaska and North Carolina are taking a more surgical approach in regulating PFAS based on these bills, targeting well-known exposures from AFFFs or from food packaging.

Packaging 40

Packaging Regulations Production Compliance 40

Broad Institute

AUGUST 2, 2023

Known to be a regulator of metabolism, we have found that in addition it has profound behavioral effects in animals and humans, even evident in population-level economic behavior. The Sabatini Lab focuses on the development and regulation of synapses in the brain and the relationship of these processes to behavior and disease.

Medical Schools 52

Medical Schools Disease Science International 52