Drug Discovery World

JULY 25, 2023

The pharmaceutical industry is constantly developing evidence-based treatments for children while there continue to be scientific advancements related to new modalities and disease understanding. General clinical pharmacology This FDA draft guidance was previously issued in 2014 but was re-issued for comments again in 2022.

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Drug Development Clinical Pharmacology Pharmacokinetics Drugs 130

Agency IQ

MAY 3, 2024

Title Type Comments Close Key Information and Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards Draft Guidance April 30 Early Alzheimer’s Disease: Developing Drugs for Treatment Draft Guidance May 13 Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the (..)

FDA 40

FDA Science Regulations Clinical Trials 40

Agency IQ

JUNE 2, 2023

6/27/2023 Notification FDORA, Section 3201 Within 180 days of the passage of FDORA, all biologics and biosimilars sponsors must submit a written notice to the FDA of all actively marketed products (i.e., These inspections will be routine surveillance rather than inspections as part of an approval application.

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FDA Science Regulations Production 40

Agency IQ

JULY 8, 2024

and the E.C.

FDA 40

FDA Science Regulations Production 40

Agency IQ

OCTOBER 6, 2023

CDER is the FDA office in charge of reviewing pharmaceuticals and therapeutic biologics. All products are received in one of two forms: A New Drug Application (or NDA, for pharmaceuticals) or a Biologics License Application (BLA, for biologics). As AgencyIQ has previously discussed , developing biosimilars is an expensive process.

FDA 52

FDA Biosimilars Science Production 52

Agency IQ

FEBRUARY 12, 2024

Accelerated Approval of Drugs and Biologics Administrative/ Procedural New Civil Monetary Penalties for Failure to Meet Accelerated Post Marketing Requirements Administrative/ Procedural Carried over from previous guidance agenda Exclusivity for First Interchangeable Biosimilar Biological Products Administrative/ Procedural Carried over from previous (..)

Biosimilars 40

Biosimilars Science Clinical Pharmacology FDA 40

Drug Discovery World

NOVEMBER 9, 2023

Dimitris Skokos, PhD, Senior Director, Cancer Immunology, Regeneron Pharmaceuticals, on: ‘Tumour-targeted costimulation via CD28 bispecific antibodies: Turning immunotherapy “cold” tumours “hot”’.

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Engineering Therapies Protein Production Science 130