Remove 2010 Remove Compounding Remove FDA
article thumbnail

Botanical drugs – what is the best way forward for regulatory and market approval?

European Pharmaceutical Review

In the US, botanical dietary supplements can be sold without US Food and Drug Administration (FDA) approval, 1 prompting many vendors to promote the use of botanical products as dietary supplements , 2 rather than pursue a path of regulatory approval. 3 Is two too few? 3 Is two too few?

FDA 103
article thumbnail

NITROSAMINES: Where now?

European Pharmaceutical Review

The US Food and Drug Administration (FDA) subsequently developed a liquid chromatography – high resolution mass spectroscopy (LC-HRMS) method for the determination of NDMA in ranitidine. FDA assigned a provisional AI of 26.5 10 It is not clear whether FDA will adopt a similar t-AI. This t-AI would be used for ≤12 months.

FDA 98
Insiders

Sign Up for our Newsletter

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

article thumbnail

8 vitamins for depression

The Checkup by Singlecare

For example, a 2010 study found that older adults who supplement with B12 and B6 tend to have a lower risk of developing depression over the next 12 years. Turmeric Turmeric coupons “Turmeric contains an active compound called curcumin, which has potential benefits, including depression,” Dr. Mandel explains.

Dosage 105
article thumbnail

14 remedies to get rid of congestion

The Checkup by Singlecare

Supplement with turmeric Curcumin is the main compound of the herb turmeric, and according to Dr. Garcia-Ibáñez, it works as a powerful antioxidant and anti-inflammatory. Garlic Garlic does contain anti-inflammatory compounds that, in theory, might reduce congestion. Eucalyptus is considered toxic to children under two.

article thumbnail

Fixed-dose combination: Considerations for design, formulation, manufacturing and analysis

Pharmaceutical Technology

Pharmaceutical companies – and the FDA – are embracing FDCs. From 1990 through 2013, the FDA approved 131 FDC products, on average 5.7 Between 2010 and the end of 2015, of the 655 New Drug Applications (NDAs) approved by the FDA, 63 were for FDCs. Of those 131 approved FDCs, 98 were oral dosage forms.

article thumbnail

The lingering menace of diethylene glycol / ethylene glycol adulteration

European Pharmaceutical Review

The 1938 law effectively changed the focus of the Food and Drug Administration (FDA) from a policing agency to a regulatory agency tasked with overseeing the safety evaluation of new drug products. There is now global awareness of this issue and FDA issued a guidance note on the problem in 2007. 5 Both compounds are limited to ≤0.1

article thumbnail

Preventing fungal contamination in pharmaceuticals

European Pharmaceutical Review

In a review on fungal-contaminated compounded pharmaceuticals and medical devices, researchers have described how the contamination of these products can be due to breaches in sterile compounding procedures. Ahmed et al. One case of drug contamination from 2021 was highlighted in the paper.