2015 Documentation Labelling 
Putting Patients First Blog
JUNE 26, 2025
This step would ensure that real-world considerations, such as off-label uses and quality-of-life impacts, are factored into revised pricing decisions. 4 Centers for Medicare & Medicaid Services, National Provider Communication Standards , April 15, 2025, https ://www.cms.gov/files/document/national-provider-communication-standards.pdf.
pharmaphorum
JULY 7, 2025
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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.
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.”
FDA Law Blog: Biosimilars
JULY 31, 2025
In 2015, FDA indicated that it increasingly was concerned about the safety of homeopathic drugs, and it claimed that the existence of the CPG limited its options to take enforcement action. Although they were unapproved new drugs, the CPG described the conditions under which FDA would allow these unapproved drugs to be on the market.
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.
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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