Vial

MARCH 1, 2024

Introduction Contract research organizations (CROs) are essential in pharmaceutical research and development (R&D). billion by 2029. Throughout its journey, PPD has been committed to consistent quality and execution, customer-aligned service, and continuous innovation to accelerate clinical trial execution.

Clinical Trials 52

Clinical Trials Clinical Research Trials Laboratories 52

Agency IQ

JANUARY 26, 2024

MDR Article 78(14) sets out the original transition deadline in going from voluntary use of the coordinated assessment process to mandatory use as May 25, 2027; for IVDs, use of the coordinated procedure becomes mandatory in May 26, 2029 for all Member States, as set out in IVDR Article 74(14). Once the E.U.

Regulations 40

Regulations Compliance Laboratories Production 40

Agency IQ

FEBRUARY 2, 2024

The proposal will be discussed at the Council of the EU Working Party on Pharmaceuticals and Medical Devices, taking place January 30. Companion diagnostics (CDx) and cancer trials: In 2023, the MDCG published guidance documents on classifying CDx. This is an extremely recent development, and an emerging area.

FDA 40

FDA Laboratories Regulations Production 40

Codon

FEBRUARY 23, 2025

million new HIV infections by 2029, undermining progress toward the UN’s goal. In 2024, the pharmaceutical company Gilead announced that a single injection of lenacapavir protected 96 to 100 percent of recipients from HIV for up to six months. By 1987, the FDA licensed zidovudine after trials showed it increased survival rates.

Clinical Trials 70

Clinical Trials Virus Vaccine DNA 70