2019 Documentation Labelling 
GMPSOP
MARCH 3, 2024
Cross contamination in the pharmaceutical industry can be described as an accidental inclusion of product of another batch or unknown foreign material into a finished batch, which was not intended or not mentioned on the label. – In 2019, the FDA publicly reprimanded 21 companies for cross-contamination.
GMPSOP
JUNE 28, 2024
Additional documents included each month. In the five years between 2019 and 2023, the FDA issued the following warning letters, closely related to ineffective deviation investigation. Packaging/labeling/Misbranding: 41 warnings vi. Additional documents included each month. All written and updated by GMP experts.
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FDA Law Blog: Biosimilars
OCTOBER 2, 2023
The new guidance is one of three policy documents dedicated to explaining FDA’s interpretation of this statutory authority and their approach to exercising scientific judgment in evaluating drug effectiveness. We are heartened to see that this latest guidance reflects many of the advances we observed in practice since 2019.
FDA Law Blog: Biosimilars
NOVEMBER 7, 2024
Provided that a brief device description, clear intended use, and list or picture of all labeling claims are made, FDA aims to review the information and provide a response generally within 7 days. Sometimes, though, there is no clear precedent, and the product’s regulatory status falls into an undiscovered country.
Pharmaceutical Technology
OCTOBER 13, 2022
In July 2019, the MHRA held up Colonis for sending a letter to physicians advertising the off-label use of the drug in children and those with renal impairment. On 22 September, the MHRA expanded the label to include the use for sleep-onset insomnia in children with ADHD. Colonis Pharma is a subsidiary company within Clinigen.
Eye on FDA
AUGUST 2, 2022
There are two means of gaining insight into the agency’s thinking about regulatory issues related to promotional communications by pharmaceutical companies; one is through the issuance of guidance documents, the other is through enforcement. But when it comes to enforcement things have changed greatly over the years.
FDA Law Blog: Biosimilars
MAY 8, 2023
a) , and related guidance documents (e.g., Post-market, manufacturers can make modifications consistent with the PCCP and document the modification in accordance with their quality system, without the need for a new marketing submission. See 21 CFR 807.81(a)(3) a)(3) and 21 CFR 814.39(a)
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