Remove 2023 Remove FDA Remove Packaging
article thumbnail

Independent Pharmacists’ Unique Role During Disaster Management Efforts

Drug Topics

1 Natural disasters have reached unprecedented levels in the past 5 years, with 2020, 2023, and 2024 being the most destructive and costly since before 1980. Taking precautions for storing medications and supplies is key to being prepared,” the FDA wrote. Innov Pharm. 2021;12(4):10.24926/iip.v12i4.4359. doi:10.24926/iip.v12i4.4359 5.

article thumbnail

Five Interesting Things To Know About Sulopenem (Orlynvah)

IDStewardship

The package insert for sulopenem recommends taking it with food to maximize bioavailability. In case you are wondering, the FDA label does not list any hepatic dose adjustments. 2023 Jan 6;76(1):78-88. 2023 Jan 6;76(1):66-77. 2023 Sep 18;77(6):937. Orlynvah [package insert]. Clin Infect Dis. Dunne MW, et al.

Packaging 130
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

FDA Announces Delayed Enforcement of DSCSA to 2024

Pharmacy Times

The start date of the package-level electronic tracking system will shift from November 27, 2023 to November 27, 2024.

Packaging 122
article thumbnail

STAT+: Pharmalittle: We’re reading about the FDA listing Novo drugs as ‘available,’ pharma layoffs, and more

STAT

Of course, this calls for a cup of stimulation, and we are opening a new package of pecan pie for the occasion. With all doses now listed as available, the FDA may soon pull it off the list, depending on its conversations with Novo about whether the company can sufficiently meet demand going forward. Sound familiar?

article thumbnail

Can China sustain a surge in oncology drug innovation?

PharmaVoice

In 2023 and 2024, approximately 30% of molecules in-licensed by Big Pharma companies came from China, Lansdell said. But the FDA remains cautious of single-country trials and prefers broader validation. The country’s trajectory may get a boost from anticipated results of a Keytruda rival’s U.S.

130
130
article thumbnail

FDA issues draft guidance on alternative tools for facility assessments

European Pharmaceutical Review

The US Food and Drug Administration (FDA) has published draft guidance on how it intends to use alternative tools for assessing drug manufacturing facilities identified in pending marketing applications. Fundamentally, this approach will establish whether facilities meet applicable requirements for FDA approval and licensure decisions.

FDA 105
article thumbnail

FDA guidance highlights E&L considerations for ophthalmic drug products

European Pharmaceutical Review

Draft guidance published by the US Food and Drug Administration (FDA) in December 2023, discussed quality considerations for topical ophthalmic drug products, including key considerations for extractables and leachables (E&L) testing. This document is revised from a version published in October 2023.

FDA 98