2015 Documentation Labelling 
European Pharmaceutical Review
AUGUST 23, 2022
Of the cGMP letters, three major types of violations – deficiencies in process validation, documentation practices (data integrity) and quality control – accounted for 26 percent, 21 percent and 15 percent of warning letters respectively. Overall, validation, documentation and quality control were the major cGMP violations.
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 Checkup by Singlecare
JUNE 5, 2025
It’s approved by the Food and Drug Administration to treat Type 2 diabetes and may be prescribed off-label for weight loss. The long-term side effects of Mounjaro haven’t been well documented but may include an increased risk of gallstones. It’s injected under the skin once per week to help control blood sugar levels.
pharmaphorum
OCTOBER 30, 2022
The two groups were also separated by a sizeable time difference, with data from the control group ranging between 1990 and 2015, while Study 03-133 started enrolling patients in 2004. Changes in standard and supportive care over the time period could also have skewed the results, said the FDA reviewer.
ISPE
JULY 19, 2023
™ started in 2015 at the ISPE Germany/Austria/Switzerland (D/A/CH) “Plug and Produce” workshop in Basel, Switzerland. Then in 2015, ISPE in Europe founded the Special Interest Group (SIG) Pharma 4.0™, Is the vendors’ documentation complete in order to assess GxP risks and GxP compliance?
The FDA Law Blog
OCTOBER 5, 2022
In 2015, FDA issued a Warning Letter to Kind LLC because, among other things, the company labeled products as healthy whereas these products provided more saturated fat per serving than permitted by the regulatory definition. The term healthy, as an implied nutrient claim, was first defined by FDA in 1994.
Pharmaceutical Technology
JANUARY 6, 2023
According to the legal documents , the plaintiffs accused the companies of “violating federal antitrust laws, alleging “per se” and “rule of reason” violations”. Novartis argued that the early release of Entresto generics could cause labelling inconsistencies.
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