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 Pharmaceuticals 52

Drug Discovery World

MAY 15, 2024

Currently in a Phase Ib/IIa study, it is believed to stabilise GAP-junction activity through regulation of connexin-43. million by 2029, according to GlobalData. Danegaptide, a small orally dosed molecule, has been noted to prevent capillary drop-out and retinal cell apoptosis. In 2019 there were >14.2

Disease 162

Disease Treatment Therapies Pharmaceuticals 162

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

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

Agency IQ

FEBRUARY 2, 2024

Diagnostics landscape analysis: Key issues and a look ahead at 2024 Diagnostic regulation in the U.S. Following significant policy proposals in recent years, 2024 is gearing up to be a profoundly impactful year for diagnostics developers and the policymakers who regulate them. is a constantly evolving topic. In the U.S., In the E.U.,

FDA 40

FDA Regulations 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 Pharmacy Drugs Licensing 105