JD Supra8d
How New Executive Orders May Affect FDA’s Medical Device Operations
Several executive orders recently signed by US President Donald Trump may have significant implications for the US Food and Drug Administration ...
Hosted on MSN24d
String Attached: FDA Battles Over CBD Tampons and Vaginal Diagnostics
FDA: We're upset because if you told us you were trying to sell a ... go to your room and study the regulations in Title 21- Code of Federal Regulations (21 CFR) Parts 1-58, 800-1299, and then ...
NBC News20d
Federal regulations paused, halting FDA's proposed ban on formaldehyde in hair products
The Food and Drug Administration announced it would decide by April 2024 whether chemical hair straightening products sold in the U.S. would be banned from using formaldehyde or ingredients that ...
Business Wire18d
Virtual Course: Developing Effective Medical Devices Post Market Surveillance and Complaint Handling Systems Under Section 522 of the Federal Food, Drug, and Cosmetic Act (FD&C ...
Why Should You Attend Global companies must meet US FDA 21 CFR 820 (The QSR) requirements in order to sell such devices in the US, no matter where they are manufactured. These companies must pass ...
JD Supra26d
FDA Issues ACNU Final Rule Establishing New Requirements for Nonprescription Drugs with an Additional Condition for Nonprescription Use
The US Food and Drug Administration (FDA)’s recently ... conditions that applicants may propose. In the newly added 21 CFR 201.67(b)(1), ACNU is defined as: “one or more FDA-approved ...
Kaleido Scope4y
Investigational Drugs or Biologics - Investigational New Drug (IND)
Principal Investigators on treatment protocols that involve an Investigational New Drug (IND) must complete Form FDA 1572, which the sponsor then submits to FDA. Form FDA 1572 is the contract between ...
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Intelligent Bio Solutions seeks 510(k) approval with drug screening study
US-based medical ... s US Food and Drug Administration’s (FDA) 510(k) clinical study plan. In June 2023, the FDA categorised the cartridge as an Opiate Test System under 21 CFR 862, a Class ...