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

FDA Law Blog: Biosimilars

AUGUST 23, 2023

DHTs have been used in clinical trials for decades in the context of measurements made when participants visit clinical trial sites. DHTs have been used in clinical trials for decades in the context of measurements made when participants visit clinical trial sites.

Production 52

Production Clinical Trials FDA Drugs 52

Agency IQ

FEBRUARY 2, 2024

There are also continued questions about regulatory capacity and what the field will look like going forward, with implications for drug developers who rely on diagnostic products. A sea change for lab tests, the implications for drug developers and outstanding questions about endpoints In the U.S.,

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FDA Laboratories Regulations Production 40

Agency IQ

NOVEMBER 3, 2023

October 1, 2027) in order to align with the next iteration of the device user fee program, the QS compliance requirement for LDTs could theoretically be in place by FY2027. A trial run: The Covid-19 EUA transition. If the agency intends for the LDT policy’s final phase to begin “not before” FY2028 (i.e.,

FDA 40

FDA Laboratories Regulations Production 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

Agency IQ

JULY 28, 2023

September 2023 Legislative deadlines in Q3 Legislation Program Tag Requirement Due Date FDORA, Section 3202 Orphan Drug Program FDA shall publish final guidance related to the draft guidance titled, “Rare Diseases: Common Issues in Drug Development.” The workshop will solicit and include industry and public feedback.

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FDA Science Biosimilars Regulations 40

Drug Target Review

MARCH 20, 2025

While the AZALEA trial primarily focused on safety, with efficacy data anticipated from the ongoing LILAC trial conducted by Anthos Therapeutics, the observed reductions in major and gastrointestinal (GI) bleeding are significant. Eliquis, Xarelto) which prevent abnormal blood clots at the expense of an increase in bleeding risk.

Therapies 52

Therapies Trials Clinical Development FDA 52