FDA Law Blog

JANUARY 4, 2023

Manufacturers who hold a biological license should report manufacturing deviations to the FDA per 21 CFR 600.14. If I use GMP grade reagents, isn’t that sufficient to support their safety? What are the general expectations on reagents used to manufacture products under an IND?

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Reagent Manufacturing Production Gene Therapy 59

FDA Law Blog

NOVEMBER 1, 2023

The PR first sets out to establish that it has authority to regulate in vitro diagnostic “test systems” as devices, and not just the system’s individual components, such as reagents, instruments, specimen collection devices, and software. For example, FDA’s regulations have exempted from certain regulatory requirements (e.g.,

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In-Vitro Regulation Manufacturing Licensing 81

pharmaphorum

SEPTEMBER 29, 2022

She regularly drafts and negotiates agreements required for the development and commercialization of pharmaceutical and medical device products, including licensing agreements, collaboration agreements, clinical trial agreements, and an array of services agreements.

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Development Regulation Production Life Science 104

The Pharma Data

DECEMBER 2, 2020

ERS Genomics – Ireland’s ERS Genomics Limited, and Germany’s Vivlion GmbH, announced a non-exclusive license agreement granting Vivlion access to ERS Genomics’ CRISPR/Cas9 patent portfolio, to enhance Vivlion’s gene editing reagents and screening services. Financial details of the agreement were not disclosed. in Mainland China.

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Drugs Gene Editing Genome Genomics 52

FDA Law Blog

AUGUST 3, 2022

In the LDT’s “toddler years,” when issuing its analyte specific reagent rule in 1997, FDA stated that it would generally exercise enforcement discretion over LDTS. Yet thirty years after FDA’s pronouncement that it could regulate LDTs, the Agency’s core position hasn’t changed: it has the legal authority to regulate LDTs.

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Pharmaceutical Technology

FEBRUARY 15, 2023

Existing compositions have proven effective but a complex landscape of intellectual property (IP) and licensing agreements make accessing these compositions complex for new parties when attempting to get to the clinic. LNP manufacturing is scalable to advanced preclinical and clinical scales with NxGen NanoAssemblr® technology.

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Bioassay RNA Development Drugs 130

The Pharma Data

DECEMBER 23, 2020

based Avacta Group entered into a license agreement with Astrea Bioseparations that allows that company to use Avacta’s Affimer platform in affinity purification applications. The agreement includes a £500,000 upfront payment to Avacta which gives Astrea the rights to generate and develop Affimer reagents in-house for affinity separation.

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Drugs Licensing Licensing Vaccination 52

The Pharma Data

MAY 4, 2021

Days after the media reports, CDSCO asked manufacturers and importers of tests and reagents to operate at maximum capacity. CDSCO also asked companies for their current stock and capacity, as well as their proposed capacity, for IL-6, D-dimer and CRP reagents and tests. . Local media outlets have reported shortages. . Other news.

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Vaccine Vaccination Manufacturing Medicine 52