FDA Law Blog: Biosimilars

OCTOBER 24, 2023

By Dara Katcher Levy — Yesterday, FDA published a new Draft Guidance, “ Communications from Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers ” (SIUU Guidance or Draft Guidance).

Labelling 64

Labelling Communication 64

Pharmaceutical Technology

JULY 29, 2022

Dr Jeremy Veenstra-VanderWeele, professor of developmental neuropsychiatry at the Columbia University Irving Medical Center, explains that agitation is seen in the minority of autistic teens, who struggle with communication. An inability to clearly communicate with others and express their wants and needs results in frustration, he adds.

Communication 105

Communication Labelling Hospitals 105

Eye on FDA

JANUARY 9, 2022

As noted in the past, there are two primary means for understanding the agency’s latest thinking with respect to promotional communications from pharmaceutical companies – the content and pattern of enforcement and the issuance of guidance documents to shed light on the parameters that exist.

Communication 64

Communication Documentation Labelling Pharmaceutical Companies 64

Eye on FDA

JULY 7, 2020

In the now distant past, enforcement from this office, then called the Division of Drug Marketing, Advertising, and Communications (DDMAC) and later re-named OPDP, was robust, with the office issuing scores of letters a year (156 were issued in 1998).

Communication 52

Communication Documentation Labelling Pharmaceutical Companies 52

pharmaphorum

FEBRUARY 26, 2021

Robert Wood’s granddaughter, Mary Lea, was the first baby to be used on the baby powder label. The litigation was settled in 2009, when Boston Scientific agreed to pay $716 million in September and an additional $1.73 Johnson’s Baby Powder also went on sale during this year and was extremely successful.

Vaccines 119

Vaccines Biosimilars Labelling Communication 119

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.

Health and Personal Care Stores 52

Health and Personal Care Stores Labelling Packaging Compounding 52

European Pharmaceutical Review

SEPTEMBER 22, 2023

Yves joined AC Immune in 2020 and is now Manager, Investor Relations and Communications. Lecanemab (BAN2401) infusion reactions and immunogenicity: results from randomized phase 2 study and an open-label extension. Brain Communications.2022;4(1). Lowe SL, Duggan Evans C, et al. Journal of Prevention of Alzheimer’s Disease.

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Immunization Immunity Vaccines Communication 97