2016 Documentation Packaging 
European Pharmaceutical Review
APRIL 8, 2025
Given that multiple work packages may often start or end together, or else take longer than others ( Figure 1 ), the introduction of new PAT requires assessment and planning by multiple departments. Any documentation, such as validation reports then helps with compliance and later regulatory submissions and requests.
Pharmaceutical Technology
JULY 18, 2025
Comstock said it is not yet clear if the report will be turned into an official agency guidance document, but it will be made publicly available. How will RFK Jr’s American dream for vaccines play out? However, the PRV program for rare pediatric diseases is at risk of expiry in September 2026, and is pending renewal.
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FDA Law Blog: Biosimilars
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.”
RX Note
JUNE 5, 2023
The Hidden Truth Studies have shown that the antineoplastic residues can be found be on the external packaging of both oral and IV drugs. Change gloves every 30 minutes during compounding or immediately when damaged or contaminated, unless otherwise recommended by the manufacturer's documentation.
FDA Law Blog: Biosimilars
JULY 15, 2025
For example, in 2016, CMS explained that, “[g]iven the continually changing pharmaceutical marketplace, we will continue to allow manufacturers the flexibility to determine the fair market value of a service when evaluating whether the service fee is bona fide or not.”
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.
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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