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Higher vitamin D levels in pregnancy may protect children from developing high blood pressure

Children appear to be at greater risk of having high blood pressure when their mothers had the high blood pressure condition called preeclampsia during pregnancy--but this adverse association may be reduced or even eliminated for children who were exposed to higher levels of vitamin D in the womb, according to a study from researchers at Johns Hopkins Bloomberg School of Public Health.

6 Oct 2020

FDA and Mexican regulatory counterparts strengthen partnership on food safety

Today, during a virtual ceremony, the U.S. Food and Drug Administration and its regulatory counterparts in Mexico - the Federal Commission for the Protection from Sanitary Risks and the National Service of Agro-Alimentary Health, Safety and Quality - enhanced a partnership to work together on food safety in both countries.

5 Oct 2020

FUJIFILM Irvine Scientific to exclusively distribute chemically defined substrate for stem cell culture

FUJIFILM Irvine Scientific today announced that it has become the exclusive, worldwide distributor of cellnest®, a recombinant peptide attachment substrate.

From FUJIFILM Irvine Scientific 30 Sep 2020

FDA releases final guidance to improve patient communication about risks of breast implants

Today, the U.S. Food and Drug Administration issued the final guidance, "Breast Implants - Certain Labeling Recommendations to Improve Patient Communication," as part of the agency's effort to help improve the information available to patients and health care professionals about the risks of breast implants.

28 Sep 2020

FDA approves first drug for patients with hypereosinophilic syndrome in nearly 14 years

Today, the U.S. Food and Drug Administration approved Nucala (mepolizumab) for adults and children aged 12 years and older with hypereosinophilic syndrome (HES) for six months or longer without another identifiable non-blood related cause of the disease.

25 Sep 2020

FDA issues updated recommendations concerning dental amalgam

Part of our role in protecting patients is to regularly evaluate, monitor and update scientific evidence on the risks from medical devices—including issues related to the materials used in devices, such as metals.

25 Sep 2020

FDA takes actions to help provide safe, more affordable drugs to Americans

Today, the U.S. Department of Health and Human Services and the U.S. Food and Drug Administration took actions to help provide safe, effective, and more affordable drugs to American patients as part of the Safe Importation Action Plan, fulfilling the aspect of the July Executive Order on drug pricing to complete the rulemaking to allow states to import certain prescription drugs from Canada.

24 Sep 2020

FDA finalizes molluscan shellfish equivalence determination for two EU Member States

Today, the U.S. Food and Drug Administration finalized a molluscan shellfish equivalence determination for two European Union (EU) Member States, Spain and the Netherlands.

24 Sep 2020

FDA issues emergency use authorization for first serology point-of-care test for COVID-19

Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first serology (antibody) point-of-care (POC) test for COVID-19.

24 Sep 2020

FDA announces requirement of class-wide labeling changes for benzodiazepines

The U.S. Food and Drug Administration announced today in a Drug Safety Communication that it is requiring an update to the Boxed Warning, the agency's most prominent safety warning, and requiring class-wide labeling changes for benzodiazepines to include the risks of abuse, misuse, addiction, physical dependence and withdrawal reactions to help improve their safe use.

23 Sep 2020

FDA proposes updates to clarify evidence related to 'intended use' of FDA-regulated products

Today, we proposed updates to our regulations to clarify the types of evidence the FDA considers when determining the "intended use" of a product.

22 Sep 2020

FDA establishes the Digital Health Center of Excellence

Today, the U.S. Food and Drug Administration announced it is launching the Digital Health Center of Excellence within the Center for Devices and Radiological Health (CDRH).

22 Sep 2020

Vitamin E is essential for proper growth of nervous system

In research with key ramifications for women of childbearing age, findings by Oregon State University scientists show that embryos produced by vitamin E-deficient zebrafish have malformed brains and nervous systems.

22 Sep 2020

Study highlights need for scientific, pharmaceutical standards for developing live biotherapeutic products

The Pharmabiotic Research Institute (PRI), Europe's only regulatory expertise centre for the development of microbiome-based drug products, has announced the publication of a review titled "Live biotherapeutic products: the importance of a defined regulatory framework".

18 Sep 2020

Omega-3 intake is associated with reduced risk of coronary heart disease events

A new study published in Mayo Clinic Proceedings provides the most comprehensive analysis of the role of omega-3 dosage on cardiovascular prevention to date.

18 Sep 2020

New comparative performance data published for authorized COVID-19 molecular diagnostic tests

Today, the U.S. Food and Drug Administration published comparative performance data for some authorized COVID-19 molecular diagnostic tests.

16 Sep 2020

New process enriches omega-3 fatty acid content in dietary supplements

A new study, co-led by University of Cincinnati researchers, describes the development of a refining process that scientists deem a superior method to help produce better dietary omega-3 health and dietary supplements containing fish oil.

16 Sep 2020

FDA takes action against Illinois-based food manufacturer for repeated food safety violations

The U.S. Food and Drug Administration announced today that Fortune Food Product, Inc., an Illinois-based processor of sprouts and soy products, has agreed to stop production until it, among other things, undertakes remedial action and complies with the Federal Food, Drug, and Cosmetic Act.

15 Sep 2020

Supplements of Human Milk Oligosaccharides may help improve gut health in adults

Supplements of Human Milk Oligosaccharides (HMOs), the sugars found in breast milk, may help improve the gut health of adults, according to new research carried out at the Quadram Institute.

14 Sep 2020

FDA issues warning letters to website operators for illegally selling opioids online

The U.S. Food and Drug Administration has issued warning letters to 17 website operators for illegally selling unapproved and misbranded opioids online in violation of the Federal Food, Drug, and Cosmetic Act.

10 Sep 2020

Supplements News and Research

Higher vitamin D levels in pregnancy may protect children from developing high blood pressure

FDA and Mexican regulatory counterparts strengthen partnership on food safety

FUJIFILM Irvine Scientific to exclusively distribute chemically defined substrate for stem cell culture

FDA releases final guidance to improve patient communication about risks of breast implants

FDA approves first drug for patients with hypereosinophilic syndrome in nearly 14 years

FDA issues updated recommendations concerning dental amalgam

FDA takes actions to help provide safe, more affordable drugs to Americans

FDA finalizes molluscan shellfish equivalence determination for two EU Member States

FDA issues emergency use authorization for first serology point-of-care test for COVID-19

FDA announces requirement of class-wide labeling changes for benzodiazepines

FDA proposes updates to clarify evidence related to 'intended use' of FDA-regulated products

FDA establishes the Digital Health Center of Excellence

Vitamin E is essential for proper growth of nervous system

Study highlights need for scientific, pharmaceutical standards for developing live biotherapeutic products

Omega-3 intake is associated with reduced risk of coronary heart disease events

New comparative performance data published for authorized COVID-19 molecular diagnostic tests

New process enriches omega-3 fatty acid content in dietary supplements

FDA takes action against Illinois-based food manufacturer for repeated food safety violations

Supplements of Human Milk Oligosaccharides may help improve gut health in adults

FDA issues warning letters to website operators for illegally selling opioids online

Event guide: 4th Extra-Hepatic Lipid-Based Nanoparticles Delivery Summit eBook

Evaluating new approaches for rare disease genomics

Expanding access to NMR with the Fourier 80 Duo

Advancing Intracellular Delivery with LumiPore®

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