FDA Law Blog
NOVEMBER 11, 2024
As dictated by the process provided for in the 2020 CARES Act, FDA announced issuance of the proposed order in a Federal Register notice and published the proposed order itself on FDA’s website. Notably, the proposed order provides that the order, if finalized, will become effective one year after the final rule is published.
The Clinical Problem Solvers
NOVEMBER 22, 2021
It notably creates a burden of proof for Indigenous trainees to prove their identity, which can provide additional stress during application and interview cycles. This is especially important when we consider the lasting role colonialism, genocide, and racism has played in attempted erasure of these communities and their culture.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
FDA Law Blog
SEPTEMBER 26, 2023
(HP&M), a leader in providing legal and regulatory support to the life sciences industries, today announced the appointment of Jeff Grizzel to the newly created position of Chief Marketing Officer (CMO). Jeff joins HP&M from Compliance Architects where he served as Vice President of Business Development.
FDA Law Blog
AUGUST 21, 2023
Investigators also found that the pharmacy sold pseudoephedrine (“PSE”) products but failed to self-certify in violation of the Combat Methamphetamine Act of 2005 (“CMEA”). After employees have been trained, regulated sellers must self-certify through the DEA website provided at the Diversion Control Division Self-Certification Page.
FDA Law Blog
JUNE 11, 2023
This Draft Guidance, in part, replaces a 2005 guidance titled “How to Comply with the Pediatric Research Equity Act.” The BPCA provides FDA with discretion to determine whether to issue, and the appropriate scope of, WRs based on the information that “may produce health benefits” in the pediatric population.
PEMBlog
AUGUST 20, 2024
2005 American Heart Association guidelines for cardiopulmonary resuscitation and emergency cardiovascular care. ECPR involves using ECMO (Extracorporeal Membrane Oxygenation) to take over heart and lung functions, offering a last-resort option that is becoming more common in large pediatric hospitals. Stratton, M., & Edmunds, K.
FDA Law Blog
FEBRUARY 28, 2023
Lenz, Principal Medical Device Regulation Expert — Since 2005, 510(k) submissions have been formatted according to FDA guidance Format for Traditional and Abbreviated 510(k)s. There are additionally places to provide attachments for test reports and other supporting documents. By Adrienne R.
Expert insights. Personalized for you.
111 
Let's personalize your content