FDA Law Blog: Biosimilars

AUGUST 14, 2023

Other interesting datapoints from her presentation: For the period from FY2000 to May of 2023, the percentages of drug manufacturing inspections with OAI classifications was lower in China (about 5% of inspections) than in the United States (8%). facility inspections are approaching traditional levels.

Dosage 52

Dosage Compounding 52

FDA Law Blog: Biosimilars

JANUARY 18, 2024

Houck — In August 2023 the Food and Drug Administration (“FDA”) and Health and Human Services (“HHS”) recommended that the Drug Enforcement Administration (“DEA”) reschedule marijuana from schedule I under the federal Controlled Substances Act (“CSA”) to schedule III. By Larry K. 21 U.S.C. § 802(16)(A). 21 U.S.C. § 802(16)(B).

Controlled Substances 69

Controlled Substances Chemotherapy Compounding Dosage 69

Pharma in Brief

JANUARY 25, 2023

We also flag what to watch out for in 2023. The most significant legislative changes concerned the Patent Act and accompanying rules/regulations. It remains to be seen how these changes will impact patent prosecution strategy in the pharmaceutical sector in 2023.

Biosimilars 52

Biosimilars Dosage Compounding Labelling 52

PharmaShots

JUNE 28, 2023

Consistent with prior periods, Enbrel continued to lose market share, and this decline was compounded by a reduction in the growth rate of the rheumatology market as a result of COVID-19. PharmaShots' analysis of Enbrel’s industry trials is depicted below: (Trials were taken on 6 Jun 2023).

Biosimilars 40

Biosimilars Insurance Coverage and Processing Dosage Compounding 40