FDA Law Blog

MAY 1, 2024

Her background also includes significant roles such as serving as an adjunct professor at the George Washington University Law School, where she coaches health law moot court teams, and engaging actively with key industry groups like the Society for Clinical Research Associates and the Food and Drug Law Institute.

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Development Drugs Compliance Generic Drugs 52

The Pharma Data

JANUARY 4, 2021

Burr Boulevard, Teaneck, NJ 07666 (3) President: Yasushi Miyazawa (4) Scope of business: Clinical research and development (5) Paid in capital: US$100,000. Outline of the new company (1) Company name: Meiji Pharma USA Inc. (2) Location: 500 Frank W. Integrated Reports: [link].

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Generic Pharmaceutical Generic Drugs Clinical Development Clinical Research 40

Pharmaceutical Technology

FEBRUARY 24, 2023

The European Federation of Pharmaceutical Industries and Associations (EFPIA), the trade organisation for branded drugs, said the proposals ‘would irretrievably sabotage’ the EU pharma industry and ‘would send Europe to the back of the queue for healthcare treatments, clinical research, jobs, and global investment’ The draft’s (..)

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Regulation Clinical Trials Clinical Trials Medicine 162

FDA Law Blog

APRIL 8, 2024

For generic drug manufacturing facilities specifically, the numbers are 63% and 87%. We recently summarized another GAO report which described challenges FDA continues to face with clinical research inspections.

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Drugs Manufacturing Generic Drugs Production 59

Cloudbyz

MARCH 5, 2024

The choice between developing a biologic or a small molecule drug often depends on the nature of the disease target, the desired mechanism of action, and the feasibility of manufacturing and delivery. Monitoring and managing immunogenicity is a complex aspect of clinical trials for biologics.

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Development Drugs Manufacturing Immune Response 77

pharmaphorum

JUNE 8, 2021

While all of the top ten best-selling oncology drugs in the US in 2019 were innovative therapies, four out of the top ten best-selling oncology drugs in China were for conventional chemotherapy. “In In addition, the pharmaceutical industry in China is still heavily dependent on generic drugs.”. About the interviewee.

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Marketing Drugs Regulation Development 105

XTalks

SEPTEMBER 14, 2020

Below are some free webinars you can register for that have delved into the topic: Continuing Clinical Research Innovations After COVID-19. The Impact of COVID-19 on Early Clinical Development – What the New Landscape Will Look Like. Addressing the Rapidly Evolving Vaccine Development Landscape.

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Vaccination Vaccine Antibody Life Science 92