ISTAND Program

by Pill Pals Customer Service | Jul 31, 2025 | News

Spotlight Events & Announcements Get Started with Your SubmissionThe Innovative Science and Technology Approaches for New Drugs (ISTAND) Program accepts submissions for qualification of types of drug development tools (DDTs) that are out of scope for existing DDT...

Doehler Dry Ingredient Solutions, LLC Recalls Member’s Mark Freeze Dried Fruit Variety Pack for Listeria monocytogenes Contamination

by Pill Pals Customer Service | Jul 31, 2025 | News

Summary Company Announcement Date: July 30, 2025 FDA Publish Date: July 31, 2025 Product Type: Food & Beverages Foodborne Illness Reason for Announcement: Recall Reason Description Potential Foodborne Illness – Listeria monocytogenes Company Name: Doehler Dry...

Digital Health Technologies

by Pill Pals Customer Service | Jul 31, 2025 | News

Digital health technologies (DHTs) offer many potential benefits in the development of medical products, including drugs. Advances in DHTs, including electronic sensors, computing platforms and information technology, provide new opportunities to obtain clinical trial...

Novel Excipient Review Pilot Program

by Pill Pals Customer Service | Jul 31, 2025 | News

FDA’s Center for Drug Evaluation and Research’s (CDER) Office of New Drugs (OND) recently launched a pilot program on Novel Excipient Review. The pilot program offers a new pathway for drug manufacturers to obtain FDA review of certain novel excipients (inactive...

ISTAND Program Submission Process

by Pill Pals Customer Service | Jul 31, 2025 | News

Submission ProcessThe 21st Century Cures Act formally established a multi-step process for Drug Development Tools (DDT) qualification. Qualification of a DDT is for a specific context of use (COU), and the qualified DDT may be used for the COU by any person in drug or...