Alta Sciences

OCTOBER 5, 2023

He brings to Altasciences over a decade of experience in management and supervisory roles for manufacturing operations and supply chains, having demonstrated an impeccable standard in ensuring adherence to compliance and cGMP policies. Altasciences helps sponsors get better drugs to the people who need them, faster.

Clinical Pharmacology 52

Clinical Pharmacology Compliance Pharmaceuticals Drug Development 52

Conversations in Drug Development Trends

FEBRUARY 21, 2024

Unflinching attention to detail is required to manage AME study participants In AME studies, our top priority is balancing participant comfort and compliance with high-quality data collection. Here are a few of our lessons learned: 1.

Clinical Trials 80

Clinical Trials Pharmacy Clinical Pharmacology FDA 80

Alta Sciences

JULY 25, 2024

Watch the webinar. jpg Synopsis Discover 10 more essential life science resources, including expert insights, tips, case studies, webinars, podcasts, posters, scientific publications, videos, and more, that you may have missed from us!

Science 52

Science Clinical Trials Clinical Pharmacology FDA 52

Agency IQ

MAY 3, 2024

Title Type Comments Close Key Information and Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards Draft Guidance April 30 Early Alzheimer’s Disease: Developing Drugs for Treatment Draft Guidance May 13 Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the (..)

FDA 40

FDA Science Regulations Clinical Trials 40

Agency IQ

FEBRUARY 2, 2024

What When it might happen Additional details FDA published a draft guidance document proposing a 180-day enforcement period for dietary supplement products to come into compliance with requirements that all New Dietary Ingredients be listed. Comments on the proposal closed on July 19. Once published, the 180-day amnesty period will start.

FDA 40

FDA Science Clinical Trials Regulations 40

Agency IQ

JUNE 2, 2023

AgencyIQ’s guidance agenda tracker FDA published a draft guidance document proposing a 180-day enforcement period for dietary supplement products to come into compliance with requirements that all New Dietary Ingredients be listed. Comments on the proposal closed on July 19. Once published, the 180-day amnesty period will start.

FDA 40

FDA Science Regulations Compliance 40

Agency IQ

MARCH 1, 2024

Start Date End Date Event Event Type Center 02/26/2024 02/26/2024 FDA/CDER and American Association of Pharmaceutical Scientists (AAPS) Hybrid Public Workshop Public CDER 02/27/2024 02/27/2024 FDA Oncology Center of Excellence Presents: Conversations on Cancer, Black History Month Program: “Real Talk: Our Stories as Black Oncologists at the FDA” Webcast (..)

FDA 40

FDA Science Clinical Trials Regulations 40