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In recent news, a federal judge has granted the U.S. Food and Drug Administration (FDA) permission to withhold COVID-19 vaccine safety data for at least six months. The FDA argued that it is overwhelmed by court orders demanding the production of records related to the authorization of Pfizer and Moderna COVID-19 vaccines.

The U.S. Food and Drug Administration (FDA) has intensified its enforcement efforts to combat the sale of misbranded, adulterated, or illegal drug and device products in the country. In a press release issued on October 31, 2019, the FDA highlighted its commitment to preventing the distribution of such products, including the court-ordered seizure of 4,229 Internet domain names associated with the sale of misbranded or adulterated items.

In response to concerns about “corporate greed” in healthcare, the Biden administration is introducing new officials in the Federal Trade Commission (FTC), Department of Justice (DOJ), and the Department of Health and Human Services (HHS) to investigate price-gouging. The move aims to enhance coordination among these agencies and address anti-competitive practices and the impact of private equity in the healthcare sector.

Summary: Recent studies suggest a connection between COVID-19 infections, vaccinations, and urinary and prostatic complications. A Hong Kong study found that men with pre-existing lower urinary tract symptoms who had a COVID-19 infection were at a higher risk of developing an enlarged prostate, leading to increased chances of urinary tract infections, urine retention, and hematuria. The virus’s presence in reproductive organs, particularly in the prostate, may contribute to inflammation and related complications.

Guidance for Industry andFood and Drug Administration StaffThis guidance represents the Food and Drug Administration’s (FDA’s) current thinking onthis topic. It does not create or confer any rights for or on any person and does not operate tobind FDA or the public. You can use an alternative approach if the approach satisfies therequirements of the applicable statutes and regulations.

Title: “Majority of Heartland Residents Reject COVID-19 Booster, Reveals Emerson College Poll” A recent poll conducted by Emerson College reveals that nearly 60% of residents in the 22 American Heartland states are reluctant to receive the new COVID-19 vaccine booster. This percentage is notably higher than the national average of 51%.

Lawyers representing the FDA argued that the agency is overwhelmed by court orders demanding the production of records related to the authorization of Pfizer and Moderna COVID-19 vaccines. The FDA requested an 18-month pause in processing a Freedom of Information Act (FOIA) request seeking COVID-19 vaccine safety data mining results, citing an “unprecedented workload.” U.S.

Recent FDA Warning Letter to Amazon.com Suggests the Agency Is Getting Tired of the Whack-a-Mole GameBy Joanne S. Hawana, Benjamin M. ZegarelliReceiving a warning letter from the U.S.

CEPI is investing up to $1.2 million to transform Quantoom Biosciences’ mRNA-containing lipid nanoparticle (LNP) vaccine materials into a thin thermostable film. This innovation aims to address storage and transportation challenges associated with traditional vaccines, as LNPs used for mRNA delivery can pose clotting or immune system activation risks. The thin film could mitigate frozen storage requirements, potentially enhancing global vaccine distribution.

A recent Cambridge study has raised concerns about Pfizer’s mRNA COVID-19 vaccines, indicating a roughly 1 in 10 chance that they may produce unintended proteins instead of the intended spike proteins. The study found that 8% of the time, Pfizer’s mRNA vaccines are mistranslated, leading to the formation of aberrant proteins. This mistranslation is attributed to Pfizer’s modification of mRNA bases, specifically using N1-methylpseudouridine.