FDA Law Blog: Biosimilars

SEPTEMBER 28, 2023

Richard Marschall, a “naturopathic doctor,” had been convicted in 2017 for a misdemeanor violation of the FDC Act for selling misbranded drugs. The issue of whether this “second violation” felony requires evidence of intent was addressed in a recent Ninth Circuit decision , United States v.

FDA

FDA Law Blog: Biosimilars

NOVEMBER 1, 2023

Unlike hospital reprocessing facilities, many clinical laboratories are overseen by laboratory directors who themselves are medical doctors. In support for this position, FDA states that hospitals that reprocess single-use devices have been viewed as manufacturers and points to its own webpage for support. This comparison is misplaced.

Laboratories

FDA Law Blog: Biosimilars

JUNE 22, 2023

CDRH may express concerns that patients will not understand when the test is appropriate for them, that they will misinterpret or overly rely on results, or that they will forego or delay visits to a doctor. See Steven R.

FDA

FDA Law Blog: Biosimilars

JULY 21, 2024

The unanimous Court held that the doctor-plaintiffs in Hippocratic Medicine had not suffered direct, causal injury. They were suing on behalf of doctors everywhere who might be affected by the legal use of mifepristone, but none of them alleged actual injury from the drug’s availability.

Nurses

The Pharma Data

MAY 15, 2023

Shamiram holds an AB from Smith College and Doctor of Medicine as well as a Master of Public Health, both from Emory University, U.S.A. He holds a Post-Doctorate in Accountancy from the Erasmus University Rotterdam, Netherlands, and a Master in Business Administration from IMD Business School in Switzerland.

Science

FDA Law Blog: Biosimilars

MAY 11, 2023

Instead, the Government takes the position that, to support an inference of intent to induce infringement, independent evidence that the generic sponsor understood its carved-out labeling to encompass patented uses and proof that petitioner expected and encouraged doctors to rely on the labeling should be necessary.

Government

FDA Law Blog: Biosimilars

MARCH 15, 2023

By updating the mammography regulations, FDA sets a minimum standard that patients be informed of whether they have dense or non-dense breast issue and the significance of breast density and suggest that patients consult their doctors about the need for additional tests.

Regulations

The Pharma Data

MAY 6, 2021

Doctors Without Borders/Medecins Sans Frontieres (MSF) also said that the decision will “increase sufficient and timely access” to these vaccines; the group asserts that many of the low-income countries in which MSF operates have only received.3% He added that “this is a monumental moment in the fight against COVID-19.”. .

Vaccine

FDA Law Blog: Biosimilars

AUGUST 21, 2023

Further, FDA has utilized a variety of strategies to call attention to safety issues through Dear Doctor letters or other forms of communication, even if directing changes to labeling is difficult. FDA, in other words, directed, and continues to direct, pregnant women to a learned intermediary.

FDA Approval

FDA Law Blog: Biosimilars

FEBRUARY 11, 2024

Thousands of doctors in the 38 states that permit the medical use of cannabis recommend marijuana to their patients and millions of patients consume medical marijuana under healthcare professionals’ guidance each year. Studies have found that marijuana access has public health benefits by reducing the rates of opioid use and opioid deaths.

Regulations

The Pharma Data

MAY 4, 2021

Multiple innovative and biosimilar products across our portfolio delivered growth, demonstrating the strength of our business and the depth and breadth of our growth drivers. billion due to recent and expected generic and biosimilar competition for certain products that have recently lost or are anticipated to soon lose patent protection.

Vaccine

The Pharma Data

AUGUST 21, 2020

Top Russian doctor quits over questionable ethics that rushed through coronavirus vaccine approval. China approves its first biosimilar of Roche’s Herceptin in HER2+ cancers. billion, making it the largest pharmaceutical industry deal this year so far.

Biosimilars

FDA Law Blog: Biosimilars

MAY 7, 2025

As such, neither Sorensen nor the entities he paid had any authority to act on behalf of a physician or unduly influence[d] the doctors decisions. The government asserted that Marchetti had relationships with, access to, and influence over doctors, but failed to show that Marchetti exercised any impermissible influence on them.

Laboratories