FDA Law Blog

OCTOBER 24, 2024

Gibbs — A recent blog post focused on the potentially negative implications of the proposed Patent Eligibility Restoration Act (PERA) for manufacturers of generic drugs and biosimilar products. The concerns raised by PERA are not limited to these industries, however. HPM is currently representing AMP in unrelated litigation.)

Manufacturing 64

Manufacturing Clinic IT Vaccination 64

GeriPal

MAY 8, 2025

Alex 06:03 Is psilocybin that’s used for medicinal purposes in your studies, for example, is that manufactured or is it derived directly from mushrooms? So it really helped form community between patients and helped build community with the palliative team that was involved. So I can say anything I want.

Illness 107

Illness IT Patient-Centered Patients 107

FDA Law Blog

OCTOBER 17, 2023

This 2022 draft guidance proposed that certain non-addictive medical products for pain or addiction treatment could be eligible for breakthrough designation, aligning with the Agency’s obligations under the Substance Use-Disorder Prevention That Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act.

Medical 53

Medical Diagnosis Healthcare Clinic 53

Common Sense Family Doctor

FEBRUARY 15, 2025

Food and Drug Administration (FDA) rule went into effect requiring television and radio advertisements for drugs to communicate risk and contraindications in a “clear, conspicuous, and neutral manner.” The annual price of risankizumab is $288,000, so this is still a huge bargain for the company given the potential returns. Kennedy, Jr.’s

Family Physician 40

Family Physician Manufacturing Family Families 40

GeriPal

MARCH 24, 2022

Ideally, there’ll be a place in the chart that actually captures the name of that person and their contact information. And I would say too, as a primary care provider, it really doesn’t take that long to ask people about a surrogate decision maker. First of all, this does feel primarily like a manufactured controversy.

Illness 72

Illness IT Healthcare Patient-Centered 72

GeriPal

DECEMBER 7, 2023

Leslie Wharton is a leader in the 26,000 member grassroots organization Elders Climate Action , which organizes older adults to create communities engaged in making a difference at local, state, and national levels. What do we do to very concretely provide heat shelters and cool shelters?

Healthcare 129

Healthcare IT Education Community 129

FDA Law Blog

MAY 21, 2024

The Attorney General also released DOJ’s Office of Legal Counsel (“OLC”) opinions providing the rationale and support for the NPRM. For each factor, the NPRM noted that DEA’s position is that additional information during the rulemaking will further inform about the appropriate schedule for marijuana. 44,597 (May 21, 2024).

Physicals 69

Physicals Medical Clinic Emergency Room 69

GeriPal

OCTOBER 31, 2024

And because MRNA vaccine someone nimbly manufacture, they can say hey, let’s just make a vaccine based on what’s currently circulating. And I was like, I don’t see much in the community right now. Now nursing homes, not really truly like community based outpatient, not really inpatient. Speaker 5 30:29 Yeah.

Vaccination 127

Vaccination IT Patient-Centered Patients 127