Big Molecule Watch

MAY 3, 2024

The updated guidance includes information on the general requirements for the content of FDA-regulated promotional communications about reference or biosimilar products and provides some examples to illustrate the FDA’s current recommendations for addressing reference, biosimilar, and interchangeable biosimilar products in product promotion.

Biosimilars 62

Biosimilars Communication Labelling Documentation 62

FDA Law Blog: Biosimilars

APRIL 25, 2024

Promotional labeling is generally any labeling other than FDA-required labeling that is devised for the promotion of a product, as well as other functions, and can include printed, audio, or visual matter that describes the product. l)(1) (e.g.,

Biosimilars 59

Biosimilars Labelling Communication 59

Eye on FDA

JANUARY 22, 2024

The communications vehicle that was the subject of the letter was a Direct-to-Consumer (DTC) television advertisement that had been submitted for agency review. There is a larger trend that may be in play – not the communications vehicle, but regarding the type of violation cited by OPDP.

Communication 86

Communication Labelling 86

FDA Law Blog: Biosimilars

APRIL 25, 2023

The technological characteristics in this context may cover a wide range of device functions, for instance, monitoring features, stimulation parameters, and communications with healthcare providers. Per section 3305(e) of the Omnibus, FDA must provide an updated guidance document by December 2024. Loose Ends IDEs.

Documentation 105

Documentation Labelling Communication 105

GMPSOP

MARCH 20, 2024

Instrument calibration procedure for pharmaceutical industry Pharmaceuticals quality assurance & validation procedures GMPSOP %title% Last Updated on March 20, 2024 Prev PREVIOUS POST Have you ever wondered if the scales at the grocery checkout show the right amount?

Documentation 52

Documentation Pharmaceutical Manufacturing Labelling Communication 52

PharmaShots

APRIL 3, 2023

It now offers DPN patients relief from chronic pain through low doses of stimulation & the battery lasts up to 10 years at low-dose settings The system also pairs with Abbott’s NeuroSphere Virtual Clinic, a connected care app for people to communicate with a physician and receive remote treatment adjustments.

Biosimilars 40

Biosimilars Diabetes Compounding Hospitals 40

Pharmaceutical Technology

APRIL 24, 2023

Since then, the drug has been used off-label in breast cancer and other types of cancer. GlobalData predicts that Comirnaty’s sales will increase by more than 20% between 2024 and 2027. However, after a period of slow movement in the field, the FDA approved the first nanodrug, Doxil, for Kaposi sarcoma in 1995.

Vaccines 59

Vaccines Immunity Immunization Medical Schools 59