The Pharma Data

APRIL 14, 2021

Food and Drug Administration (FDA) has approved the company’s supplemental Biologics License Application for Xolair® (omalizumab) prefilled syringe for self-injection across all approved U.S. with Xolair since its initial approval in 2003. today announced that the U.S. indications. In the U.S., In the U.S., About Xolair.

FDA Approval 52

FDA Approval Clinical Development FDA Licensing 52

Agency IQ

JUNE 16, 2023

Highlights of the EPA’s Unified Agenda for Spring 2023 The Office of Management and Budget has released the Unified Agenda for Spring 2023, which outlines the regulations that agencies expect to release in 2023 and 2024. This information would be used in considering the regulation of asbestos.

Regulations 40

Regulations Compliance Production Science 40

FDA Law Blog: Biosimilars

JANUARY 9, 2024

After its enactment in 2003, successive administrations thwarted its implementation by declining to certify to Congress that importation will pose no additional risk to public health and safety and will result in a significant reduction in cost to American consumers, as the statute requires. This must be a U.S.-based

FDA Approval 59

FDA Approval FDA Drugs Compliance 59

Drug & Device Law

JULY 31, 2023

2003), an Internal Revenue Service regulation, excluded liability for “product” refund, repair or replacement. 23, 37 (2003) (“the phrase refers to the producer of the tangible goods that are offered for sale, and not to the author of any idea, concept, or communication embodied in those goods”). Medicis Pharmaceutical Corp. ,

Production 52

Production International Trials Government 52

Drug & Device Law

FEBRUARY 20, 2023

Without an FDA license to produce another design, [defendant] was legally prohibited from distributing either [alternative design advocated by plaintiffs] at the time [plaintiff] received her vaccinations. 2003), aff’d , 810 N.Y.S.2d As a result, appellee was prohibited by federal law from employing either of these [alternatives].

FDA 59

FDA FDA Approval Testimonials Vaccine 59

Drug & Device Law

MAY 26, 2023

We are not looking do either of those, but we will weigh in on what NPP means for non-product liability cases involving FDA-regulated medical products. A state cannot regulate commerce occurring wholly outside its borders. 644 (2003), but not to Pike. Ogden , 22 U.S. Wisconsin , 228 U.S. 115 (1913), and Savage v. 501 (1912).

Regulations 59

Regulations Production FDA FDA Approval 59