09 Apr 2020

FDA Warns Seller Marketing Dangerous Chlorine Dioxide Products that Claim to Treat or Prevent COVID-19

By David Arvelo

WASHINGTON DC (April 9, 2020) — The US Food and Drug Administration has issued a warning letter to a seller that markets fraudulent and dangerous chlorine-dioxide products known as “Miracle Mineral Solution” for prevention and treatment of “Novel Coronavirus Disease 2019” (COVID-19).

03 Apr 2020

FDA Coordinates National Effort to Develop Blood-Related Therapies for COVID-19

By David Arvelo

WASHINGTON DC (April 3, 2020) — The US Food and Drug Administration continues to play a critical role in accelerating medical countermeasures to treat and prevent COVID-19. As part of the response to this pandemic, the agency is taking the lead on a national effort to facilitate the development of, and access to, two investigational therapies derived from human blood.

02 Apr 2020

FDA Requests Removal of All Ranitidine Products (Zantac) from the Market

By David Arvelo

WASHINGTON DC (April 2, 2020) — On March 1, The US Food and Drug Administration announced it is requesting manufacturers withdraw all prescription and over-the-counter (OTC) ranitidine drugs from the market immediately.

30 Mar 2020

Coronavirus (COVID-19) Update: FDA Expedites Review of Diagnostic Tests to Combat COVID-19

By David Arvelo

WASHINGTON DC (March 30, 2020) — The US Food and Drug Administration has been providing unprecedented flexibility to labs and manufacturers to develop and offer COVID-19 tests across the US. The FDA’s regulations have not hindered or been a roadblock to the rollout of tests during this pandemic.

24 Mar 2020

Insulin Gains New Pathway to Increased Competition

By David Arvelo

WASHINGTON DC (March 24, 2020) — Today is a historic day and a landmark moment for patients with diabetes and other serious medical conditions, as insulin and certain other biologic drugs transition to a different regulatory pathway. This regulatory transition, mandated by Congress and implemented by the FDA, is incredibly important for patients.

15 Aug 2019

FDA Proposes New Required Health Warnings with Color Images For Cigarette Packages and Advertisements to Promote Greater Public Understanding of Negative Health Consequences of Smoking

By David Arvelo

 

13 Aug 2019

FDA Warns Consumers about the Dangerous and Potentially Life-Threatening Side Effects of Miracle Mineral Solution

By David Arvelo

DALLAS, TEXAS (August 12, 2019) — The US Food and Drug Administration is warning consumers not to purchase or drink a product sold online as a medical treatment due to a recent rise in reported health issues.

09 Aug 2019

FDA Notifies Four Companies to Remove 44 Flavored e-Liquid and Hookah Tobacco Products From the Market for Not Having Required Marketing-Authorization

By David Arvelo

DALLAS, TEXAS (August 9, 2019) — The US Food and Drug Administration issued warning letters notifying four companies that 44 flavored e-liquid and hookah tobacco products do not have the required marketing authorization, and thus cannot be legally sold in the United States.

31 Jul 2019

Department of Health and Human Services (HHS) Announces New Action Plan to Lay Foundation for Safe Importation of Certain Prescription Drugs

By David Arvelo

DALLAS, TEXAS (July 31, 2019) — The US Department of Health and Human Services (HHS) announced today that HHS and the US Food and Drug Administration (FDA) are publishing a Safe Importation Action Plan - PDF* that outlines two potential pathways that would lay the foundation for the safe importation of certain drugs originally intended for foreign markets.

02 Jul 2019

FDA revises 2017 Fish Advice for Pregnant and Breastfeeding Mothers and Young Children

By David Arvelo

WASHINGTON DC (July 2, 2019) — “Fish and shellfish are an important part of a well-rounded diet. However, we know many consumers worry about mercury in fish and even choose to limit or avoid fish because of this concern. In fact, we have seen that women in the US who are pregnant are consuming far less than the recommended amount of seafood,” said Susan Mayne PhD, director of the Federal Drug Administration's [FDA] Center for Food Safety and Applied Nutrition.

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