Questions tagged [fda]

Isabella Fri Sep 06 2024 | 7 answers 2071

I don't understand this question. Could you please assist me in answering it?

CryptoQueen Fri Sep 06 2024 | 5 answers 1113

Excuse me, I was just perusing through some information on Jovi Patch and I came across a question that has been lingering in my mind. Could you please clarify whether Jovi Patch has been approved by the Food and Drug Administration, or FDA, for use? I understand that when it comes to medical products, especially those involving health and wellness, it's crucial to ensure that they have undergone rigorous testing and evaluation to ensure safety and efficacy. So, could you please provide some insight into this matter? Thank you in advance for your assistance.

Caterina Thu Sep 05 2024 | 6 answers 1393

Can you elaborate on the Gdufa fee? I'm curious to understand its purpose and how it applies to the pharmaceutical industry. Is it a mandatory fee that drug manufacturers need to pay, and if so, what are the specific circumstances that necessitate its payment? Additionally, how does the revenue generated from this fee contribute to the FDA's operations, and are there any exemptions or discounts available for small or low-income drug manufacturers?

Michele Thu Sep 05 2024 | 0 answers 0

Excuse me, could you please clarify for me what exactly does the acronym "RTR" stand for within the context of the Food and Drug Administration, or FDA? I'm quite interested in understanding the specific role or process that this term encompasses within the agency's operations. It would be greatly appreciated if you could elaborate on its significance and how it contributes to the FDA's overall mission and functions.

GangnamGlitzGlamourGloryDays Thu Sep 05 2024 | 0 answers 0

Could you please clarify what FDA PMR stands for and its significance in the context of the healthcare industry? I'm particularly interested in understanding how it relates to the regulation of medical devices and drugs, and what role it plays in ensuring the safety and efficacy of these products for patients. Additionally, I'm curious about the process involved in submitting a PMR and the potential consequences of failing to comply with FDA regulations in this area.