Drug Discovery World

JULY 25, 2023

Furthermore, the guideline discusses the data requirements to support paediatric clinical investigations for both drugs and devices as well as the procedures needed for sedation in paediatric clinical investigations. The guidance is for pharmaceutical companies conducting paediatric clinical trials in the EU using the PIP procedure.

Drug Development 130

Drug Development Clinical Pharmacology Pharmacokinetics Drugs 130

Agency IQ

OCTOBER 20, 2023

BsUFA III regulatory science pilot offers progress report, fields stakeholder criticisms and questions This week, FDA and its grantees briefed stakeholders on the status of research projects funded through the Biosimilar User Fee Act (BSUFA III) Regulatory Science Pilot Program. Developing biosimilars is an extensive and expensive process.

Science 40

Science Biosimilars FDA Production 40

Agency IQ

JUNE 2, 2023

What We Expect the FDA to do in June 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. The Agenda is typically updated twice per year, and it was last released in early January 2023.

FDA 40

FDA Science Regulations Compliance 40

Agency IQ

MAY 3, 2024

12/29/2023 FDORA, Section 2512 Shortages : FDA must review its policies related to drug or biologic expiration dates and issue draft guidance or revise existing guidance on stability testing data in drug and biological product submissions.

FDA 40

FDA Science Regulations Clinical Trials 40

Drug Discovery World

NOVEMBER 9, 2023

Ahead of protein and antibody engineering conference PEGS Europe 2024 in Lisbon, DDW’s Megan Thomas looks at what to expect from each track of the annual biologics technology meeting. Iain Moal, PhD, Scientific Leader, Computational Antibody Engineering, GSK, on: ‘Learning antibody binding affinity using FACS and NGS’.

Engineering 130

Engineering Protein Production Therapies Science 130

The Pharma Data

MAY 2, 2022

The companies expect to complete submission of the NDA for treatment of MDD in the second half of 2022; associated filing for postpartum depression anticipated in the first half of 2023. Sage Therapeutics, Inc. Nasdaq: SAGE) and Biogen Inc. Nasdaq: BIIB) initiated a rolling submission of a New Drug Application (NDA) to the U.S.

Treatment 52

Treatment Clinical Pharmacology Drugs Biosimilars 52

Agency IQ

SEPTEMBER 29, 2023

What We Expect the FDA to do in October 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. AgencyIQ October 1 Nitrosamine testing due to FDA.

FDA 40

FDA Science Regulations Production 40