FDA Law Blog: Biosimilars

AUGUST 9, 2023

Houck — If a patient presents a paper prescription for a controlled substance to a pharmacy and the pharmacy cannot fill it, the patient can take that prescription to another pharmacy. Transfer of Electronic Prescriptions for Schedule II-V Controlled Substances Between Pharmacies for Initial Filling, 88 Fed.

Controlled Substances 52

Controlled Substances Documentation Communication 52

FDA Law Blog: Biosimilars

AUGUST 16, 2023

Prior to the CytoDyn letter in 2022, OPDP issued a Warning Letter in 2021 to CooperSurgical for a DTC video entitled “Paragard: Family Planning During the Pandemic” which failed to communicate ANY risk information. OPDP first took issue with a headline and graph presented on page 7 of the 12-page brochure. What does this mean ?

Labelling 52

Labelling Controlled Substances Communication 52

Pharmaceutical Technology

JUNE 14, 2023

According to GlobalData’s Drugs database, 97% of marketed drugs are small molecule products and analysis shows an increased CMO appetite for specialized capabilities, with controlled substance and containment facilities highly sought after [i]. This is achieved via a controlled vacuum.

Controlled Substances 52

Controlled Substances Communication 52

Quality Matters

MAY 23, 2023

This alone can present serious risks to patients’ health and public health. The challenges associated with online pharmacies are not just limited to the distribution of counterfeit medicines – they also include the potential to exacerbate addiction and substance abuse through the availability of controlled substances.

Online Pharmacies 52

Online Pharmacies Controlled Substances Packaging Communication 52