article thumbnail

Approaches for Quelling Stigma related to COVID-19

BMJ

quarantine-breakers”) or video clips of people shouting at or even physically assaulting Wuhanese or people who visited Wuhan after the outbreak. 2014 (28 August). The content of many social media posts in China have stigmatized Wuhan or Wuhanese, for example posts engaging in name-calling (e.g., doi:10.3389/fcomm.2020.00039

article thumbnail

A Question 30 Years in the Making: Would a Final LDT Rule Withstand Judicial Scrutiny?

FDA Law Blog

Indeed, recent jurisdictional developments suggest that a wide of array of stakeholders could have standing to challenge the Agency’s attempt to restrict access to commonly used LDTs, including individual laboratories, hospitals, physicians and healthcare providers who routinely use these tests, and patients who depend on them.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

FDA’s Issues Draft Guidance on Accelerated Approval: A Substantial Evidentiary and Procedural Overhaul to this High-Profile Pathway

FDA Law Blog

Sasinowski On December 5, 2024, FDA published a new draft guidance on accelerated approval providing a much needed and substantial update to its guidance on the pathway. However, the 2014 Guidance cannot be ignored entirely. By Charles G. Raver & James E. Valentine & Ellis Unger & Frank J.

Clinic 64
article thumbnail

Surely You Must be Kidding, PTO?!? “No, and Don’t Call Me Shirley!” – The Seemingly Slapstick (But Yet Unfunny) World of Recent Patent Term Extension Decisions (PART 2)

FDA Law Blog

A surrogate endpoint is a marker, such as a laboratory measurement, radiographic image, physical sign or other measure that is thought to predict clinical benefit but is not itself a measure of clinical benefit. The use of a surrogate endpoint can considerably shorten the time required prior to receiving FDA approval.

Clinic 59
article thumbnail

I Hear You Knockin’… Preparing for and Managing DEA Inspections (Part 2)

FDA Law Blog

Houck — Although we blogged on Drug Enforcement Administration (“DEA”) cyclic and on-site inspections in June 2014, we thought it helpful to update registrants on what they can expect as diversion investigators resume activities following the Covid-19 shutdown. The investigators select the drugs they will audit.

article thumbnail

I Hear You Knockin’… Preparing for and Managing DEA Inspections (Part 2)

FDA Law Blog

Although we blogged on Drug Enforcement Administration (“DEA”) cyclic and on-site inspections in June 2014, we thought it helpful to update registrants on what they can expect as diversion investigators resume activities following the Covid-19 shutdown. The investigators select the drugs they will audit.

article thumbnail

When to Go to Urgent Care for a Sore Throat: How Can Urgent Care Help?

Doctor On Demand

Urgent care clinics provide quick diagnoses and treatments, including antibiotics if needed. When to use telehealth for a sore throat Telehealth offers a convenient way to treat a sore throat and also provides guidance when you’re unsure if you need in-person care. This requires emergency treatment.

ER 52