2015 Labelling Packaging 
European Pharmaceutical Review
AUGUST 23, 2022
However, the researchers noted that a larger number of warning letters were issued to pharmaceutical manufacturers (ie, by CDER) than to medical device manufacturers (by CDRH) between 2015 and 2020. The major reasons for this were poor cGMP compliance and misbranding.
Safe Biologics
NOVEMBER 12, 2023
6 would prevent the HHS Secretary from requiring a switching study as part of the data package to receive the interchangeable designation. This is the first biosimilar approved to treat systemic juvenile idiopathic arthritis, and the 43rd biosimilar approved by the FDA since 2015. However, S.6 ASBM surveys of U.S.
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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 8, 2023
In the past, package inserts were not always reliable sources of information regarding medication safety during lactation. As a general rule, breastfeeding is considered acceptable when the relative infant dose is <10%.
RX Note
OCTOBER 5, 2023
Such events may be related to professional practice and healthcare products, procedures and systems, including prescribing; order communication; product labelling, packaging and nomenclature; compounding; dispensing; distribution; administration; education; monitoring; and use.
RX Note
JUNE 5, 2023
A simple method is to use a small adhesive label to mark the position and thus produce a measure with just one graduation.) Furthermore, in late August 2020, the FDA approved labelling changes for hydrochlorothiazide (HCTZ) to inform clinicians and patients about the slight risk of developing non-melanoma skin cancer.
pharmaphorum
AUGUST 25, 2021
In 2015, PEPFAR reached out to Gilead and said they were working with the government in Sub-Saharan Africa. If you get past the regulatory hurdles, then you have to look at labelling requirements, packaging requirements, and quality assurance requirements.”.
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