Vial

FEBRUARY 29, 2024

Contract research organizations (CROs) are an integral partner of the drug development process, as they play a pivotal role supporting clinical trial conduct for pharmaceutical, biotechnology, and medical device sponsor companies. That is, how many clinical trials are actually managed by these organizations?

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Clinical Trials Trials Clinical Research Drug Development 52

Agency IQ

AUGUST 2, 2024

While the work on the pharma package will likely take quite some time, another deadline is coming up fast: the full transition of all clinical trials from the Clinical Trials Directive to the Clinical Trials Regulation.

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Regulations Clinical Trials Production Trials 40

Agency IQ

JANUARY 26, 2024

Class A devices needed to be IVDR-ready on the original date (May 26, 2022), but class D had until May 2025, class C until May 2026, and class B and sterile class A until May 2027. These requirements are similar to what is already required for critical pharmaceutical products. In-house tests (in the U.S. Once the E.U.

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Regulations Compliance Laboratories Production 40

Vial

DECEMBER 7, 2023

billion by 2027 , at a compound annual growth rate (CAGR) of 45.7% Although this staggering growth rate is related to the rise in adoption of cloud-based digital technology, as well as the need for more efficient drug discovery approaches, traditional methods continue to hold significant value in the pharmaceutical world.

Drugs 52

Drugs Clinical Trials Trials Treatment 52

FDA Law Blog: Biosimilars

JULY 24, 2023

Koblitz — Neither Jazz Pharmaceuticals nor Avadel CNS Pharmaceuticals has taken the battle of sodium oxybate—a drug approved to treat narcolepsy—lying down. After suing each other in patent litigation and Avadel’s suit against FDA challenging the Agency’s authority to compel patent certifications, it’s Jazz’s turn to sue FDA.

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FDA Regulations Clinical Trials Production 52

The Pharma Data

JANUARY 26, 2021

As an Orphan Drug, Uttroside-B may benefit from a seven-year market exclusively following marketing approval, grant funding for clinical trials that contribute to marketing approval, protocol assistance, and tax credits. billion by 2027. About Q BioMed Inc. Q BioMed Inc.

FDA 40

FDA Treatment Small Molecule Drugs 40

Agency IQ

FEBRUARY 15, 2024

These topics include administrative, advanced manufacturing, the Animal Rule, antimicrobials, biosimilars, blood products, breakthrough devices, cell and gene therapy products, CGMP, clinical pharmacology, clinical trials, clinical/medical guidance, combination products, communication, compounding, cybersecurity, device software, digital health technologies, (..)

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FDA Science Biosimilars Clinical Trials 40