Drug Discovery World

NOVEMBER 9, 2023

Thereafter, there will be two presentations, which are: Jan Terje Andersen, PhD, Professor, Department of Pharmacology, University of Oslo; Research Group Leader, Department of Immunology, Oslo University Hospital, on: ‘Biology-based engineering of versatile antibody and albumin technologies’.

Engineering 130

Engineering Protein Production Therapies Science 130

Agency IQ

OCTOBER 6, 2023

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). There were 21 NMEs added to the FDA’s Purple Book , which provides information about all biological products licensed by the FDA. Read the AgencyIQ analysis here.

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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

FEBRUARY 12, 2024

A new real-world evidence guidance on the list is meant to address the integration of randomized controlled trials for drug and biological products into routine clinical practice. Other guidances of note include one on the “study of sex differences in the clinical evaluation of medical products.”

Biosimilars 40

Biosimilars Science Clinical Pharmacology FDA 40

Agency IQ

SEPTEMBER 29, 2023

Due to the presence of nitrosamines in certain drug products, FDA had required that drug manufacturers conduct an initial risk assessment of approved or marketed products, with an initial completion date of October 1, 2021, and then confirmatory testing due by October 1, 2023. AgencyIQ October 1 Nitrosamine testing due to FDA.

FDA 40

FDA Science Regulations Production 40

The Pharma Data

DECEMBER 17, 2020

With experiences attained in licensing and business development functions from Amgen, Baxter and Johnson & Johnson, Mr. Bliss introduced himself in Mandarin Chinese. The Phase I clinical trial is ongoing in Taiwan in Australia, with results expected in 2021. SOUTH SAN FRANCISCO, Calif. and TAIPEI, Taiwan, Dec.

Clinical Trials 40

Clinical Trials Trials Pharmaceutical Companies Clinical Pharmacology 40

The Pharma Data

OCTOBER 15, 2020

marketing and diagnostics. Trevi Therapeutics – Shashank Rohatagi was named vice president of Pharmacology and Clinical Phrarmacokinetics. Shashank joins Trevi from Metrum Research Group where he was senior principal scientist for Clinical Pharmacology. At Spark, he served as head of U.S. Katherine S.

Pharmaceuticals 52

Pharmaceuticals Clinical Pharmacology Medical Schools Vaccine 52

Agency IQ

OCTOBER 27, 2023

and Annex 1 Conference Joel Welch December 18 RAPS RAPS Webcast: FDA Forecast: What’s Next for the FDA in 2024 AgencyIQ Speakers December 21 HL7 REMS Public Call PDUFA Dates expected in November and December PDUFA dates represent the expected date of a regulatory decision by the FDA on a New Drug Application or Biologics License Application.

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Agency IQ

DECEMBER 1, 2023

December 2023 Clinical Holds in Medical Device Investigations (Proposed Rule) The proposed rule would create procedures for suspending, i.e., imposing a hold (a “clinical hold”) on, a clinical investigation of a medical device. The following PDUFA dates were obtained from publicly available sources.

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Agency IQ

FEBRUARY 15, 2024

Priority A List. CDRH FY2024 Guidance Agenda Device software Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers CDRH Final By 10/1/24 Priority B List CDRH FY2024 Guidance Agenda Post-approval reporting 3D Printing Medical Devices at the Point of Care CDRH Draft By 10/1/24 New on CDRH’s guidance agenda. Priority B List.

FDA 40

FDA Science Biosimilars Production 40

Agency IQ

JULY 12, 2024

Proposed Rule Pediatric Study Plan Requirements for New Drug and Biologics License Applications October 2024 FDA is proposing to amend its existing regulations and add new regulations pertaining to submission of required initial pediatric study plans (iPSPs) under the Federal Food, Drug, and Cosmetic Act (FD&C Act). and the E.C.

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