The FDA Law Blog

OCTOBER 5, 2022

The proposed rule is intended to align with current nutrition science, the Dietary Guidelines for Americans 2020-2025 and the 2016 nutrition labeling regulation (which also was intended to align with the Dietary Guidelines for Americans). FDA also announced it would be re-evaluating the regulatory criteria for use of the “healthy” claim.

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The FDA Law Blog

FEBRUARY 21, 2024

This amendment marks the first significant revision of Part 820 since 1996, which established the Quality System (QS) regulation and “included requirements related to the methods used in, and the facilities and controls used for, designing, manufacturing, packaging, labeling, storing, installing, and servicing of devices intended for human use.”

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The Digital Apothecary

APRIL 26, 2019

This includes companies providing on-demand drug deliveries, alternative packaging solutions, or other personable entreaties to entice customers to get their medications filled at their location. The authors went back and analyzed much of the past data using previous methods to estimate costs in dollars and reflect inflation for 2016 prices.

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ISPE

MAY 9, 2023

Improvements have been observed by various regulatory agencies in Latin America for the acceptance and implementation of international standards—for instance, the ICH Common Technical Document (CTD) format. Additional required information beyond ICH guidelines, or non-value-added documents (e.g., 6, and 2.3.S.7 7 are required.

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ISPE

SEPTEMBER 11, 2023

4 , 5 Additionally, reducing shipping limitations—such as packaging, storage, and transportation durations—helps speed up patient access in certain instances while ensuring there is no negative impact to the product’s critical quality attributes (CQAs). 12 April 2016. October 2022. www.fda.gov/media/162157/download 7 Okwudire, C.

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PharmaShots

JUNE 1, 2023

These new results reinforce our differentiating data package for PDC*lung01. The durability of response in all first-line stage IV (metastatic) NSCLC patients with partial response or stable disease is particularly encouraging and provides hope for this patient group where there is still a significant unmet need. 2015; Zhu et al.,

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The Thyroid Pharmacist

JULY 29, 2022

Feel free to use my own health timeline as a guideline to document your health journey. Most filter manufacturers have pictures on their filter packaging that indicate what they will and will not filter, along with the MERV rating. Published 2016 Jul 19. Published 2016 May 24. 2016 Sep;124(9):1479-86. 2017.00050.

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