Agency IQ

AUGUST 2, 2024

While generic drugs technically pre-dated the law (look up “Paper NDAs” if you’re interested), the law turbocharged the ability of generics to come to market. While this would not affect existing vouchers, it would prevent FDA from issuing new ones after September 2026.

FDA 40

FDA Science Regulations Biosimilars 40

Agency IQ

JUNE 28, 2024

In addition, the law prohibits the sale of carpets or fabric treatments containing PFAS as of January 1, 2023. Under the law, beginning in January 2026, manufacturers who sell products in Minnesota with intentionally added PFAS must submit a significant amount of information regarding the product.

Production 40

Production Regulations Compliance Packaging 40

Agency IQ

JUNE 9, 2023

What will the orphan drug market exclusivity haircut mean for industry? Here, we’re starting some deeper analysis of aspects of the proposal package with a look at the impact of orphan drug provisions, seeing what impact the new provisions and the surrounding uncertainty might have on innovation. Orphan designation in the E.U.

Marketing 40

Marketing Biosimilars Regulations Drugs 40

The Pharma Data

JULY 6, 2021

At its Investor Update, GSK announced a package of new financial outlooks and ambitions. Adjusted operating margins are expected to improve from the current mid-20s level to over 30% by 2026. Cash generated from operations is expected to exceed £10 billion by 2026.

Government 52

Government Vaccine Production Science 52

Agency IQ

MARCH 29, 2024

The proposal builds upon EPA’s final standards for federal greenhouse gas emissions standards for passenger cars and light trucks for model years 2023 through 2026. Specifically, the NPRM proposed changes to manifest regulations for shipments of hazardous waste that are exported for treatment, storage, and disposal.

Regulations 40

Regulations Compliance Production Government 40

Agency IQ

DECEMBER 15, 2023

The allowance or “variance” to the prohibition on the open burning of hazardous waste was established at a time when there were no alternatives to the safe treatment of waste explosives. This routine Methods Update Rule (rMUR) was proposed in February 2023. EPA is not considering methods for new analytes in this routine MUR.

Regulations 40

Regulations Compliance Production Government 40