Agency IQ

JUNE 16, 2023

0910-AI26 September 2023 March 2023 Final Rule Stage Biologics License Applications and Master Files The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) deemed any biological product approved in a new drug application (NDA) to be a biologics license application (BLA) on March 23, 2020.

Regulations 40

Regulations FDA Science Production 40

Agency IQ

JUNE 2, 2023

Within the realm of FDA-required labeling, there are currently a few different types of information a sponsor might develop specifically for patient use: medication guides, instructions for use (IFU), consumer medical information (CMI) and patient package inserts (PPI).

FDA 40

FDA FDA Approval Production Regulations 40

Agency IQ

JULY 28, 2023

September 2023 Final Rule Stage Biologics License Applications and Master Files The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) deemed any biological product approved in a new drug application (NDA) to be a biologics license application (BLA) on March 23, 2020.

FDA 40

FDA Science Biosimilars Regulations 40

Agency IQ

JUNE 16, 2023

The AWIA, section 2009(a), also revises the scope of a consolidation plan under the Safe Drinking Water Act (SDWA), subsection 1414(h)(1), to include a contract for significant managerial or administrative functions of a PWS. This rule is the second of two rulemakings (Phase II) that EPA is undertaking to update its FOIA regulations.

Regulations 40

Regulations Compliance Production Science 40

Codon

FEBRUARY 23, 2025

By 1987, the FDA licensed zidovudine after trials showed it increased survival rates. All the participants in the study received PrEP because it would have been unethical to deprive them of an existing, licensed preventative. They’ve created voluntary licensing agreements with six other pharmaceutical manufacturers (Dr.

Clinical Trials 68

Clinical Trials Virus Vaccine DNA 68

Drug & Device Law

JULY 31, 2023

2009 WL 1142570, at *8 (Conn. April 1, 2009) (contract to revise and encrypt plaintiff’s existing software did not involve a UCC good); Bobryk v. 2009); see also Data Processing Services, Inc. 2009), aff’d in part & rev’d in part on irrelevant grounds , 659 F.3d Thomas Nelson Publishing , 2009 WL 612385, at *2 (E.D.

Production 52

Production Trials International Government 52

Drug & Device Law

MAY 30, 2022

The law presumes that licensed doctors know what they are doing. W]e believe that a drug manufacturer cannot be required legally to foresee that a licensed physician will disregard express warnings regarding a drug’s use. . . . Wyeth , 2009 WL 3244890, at *?? (Pa. 2009 WL 6411752, at *?? (Pa. Fortenberry , 530 So.2d

Testimonials 59

Testimonials Doctors Production Laboratories 59