FDA Law Blog

JUNE 7, 2021

Subpart H) pathway in 2014, then issued it as final guidance in January 2019. However, the FDA guidance goes on to say in some cases, additional context is needed by specifically inserting a sentence in the indications statement that: no clinical benefit has been established. This has been a decision we’ve been closely following.

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Clinic IT Private Practice Utilities 98

FDA Law Blog

JANUARY 7, 2024

To better understand FDA’s approach in classifying postmarketing pregnancy studies as PMRs or PMCs, we reviewed all postmarketing requirements (PMRs) and postmarketing commitments (PMCs) related to maternal and fetal outcomes in FDA’s PMR/PMC database for drugs approved in the ten-year period from January 2014 through December 2023.

Vaccination 59

Vaccination IT Clinic 59

FDA Law Blog

APRIL 7, 2025

Zenrelia comes with serious warnings, including a boxed warning against the use of Zenrelia during vaccination. CVM also objected to the truncation of other information about the timing of vaccines in these promotional materials. Zenrelia promotional materials also included claims about clinical data that the Agency found actionable.

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Vaccination IT Manufacturing Screening 64

PEMBlog

JANUARY 17, 2024

Camargo, Clinical Trial: Comparative Effectiveness of Cephalexin Plus Trimethoprim-Sulfamethoxazole Versus Cephalexin Alone for Treatment of Uncomplicated Cellulitis: A Randomized Controlled Trial, Clinical Infectious Diseases, Volume 56, Issue 12, 15 June 2013, Pages 1754–1762, [link] Liu C, Bayer A, Cosgrove SE, et al. What is it?

IT 59

IT Patients Diagnosis Clinic 59

PEMBlog

MAY 9, 2024

Common variants associated with general and MMR vaccine-related febrile seizures. Nat Genet 2014; 46:1274. Vaccines don’t cause autism, but they might cause febrile seizures. The absolute risk is small, and genetic susceptibility likely plays a role in seizures after vaccines. And you know what?

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Illness Vaccination Families Family 59