FDA – Courthouse News Service

FDA Panel Unanimously Backs Johnson & Johnson Vaccine

February 26, 2021February 26, 2021 NINA PULLANO

coronavirus, FDA, Johnson & Johnson, vaccines

A panel of experts said the agency should authorize emergency use of the single-dose vaccine that is easier to transport and store.

Business Environment Government Health

Cattle Drugs

February 24, 2021February 25, 2021 BRIEF

California, cattle, drugs, FDA, food safety

A federal court in California declined to dismiss a suit challenging the Food and Drug Administration’s approval of the animal drug Experior, which is supposed to reduce the amount of ammonia released from cattle waste.

Business Government Health

FDA Report Means More Promise for One-Shot Covid-19 Vaccine

February 24, 2021February 24, 2021 NINA PULLANO

coronavirus, FDA, pharmaceuticals, regulation, vaccines

A single-dose vaccine candidate developed by Johnson & Johnson prevents deaths and hospitalizations, though with less efficacy than Moderna and Pfizer’s products.

Appeals Government Health

Stem Cells

February 12, 2021February 16, 2021 BRIEF

11th circuit, FDA, intervenors, pharmaceuticals

The 11th Circuit ruled that it lacks jurisdiction over patients’ appeal to intervene in an action between a corporation running a stem cell “bank” and the U.S. Food and Drug Administration, which sued the bank to prevent it from distributing stem cell products until it obtains approval.

Appeals Business Law

Bacardi Case Pits Gin Against Florida Food-Safety Laws at 11th Circuit

February 10, 2021February 11, 2021 IZZY KAPNICK

11th circuit, alcohol, FDA, Florida, food safety

Botanicals are essential to the creation of gin, but a class says Bombay Sapphire’s “grains of paradise” run afoul an antiquated Florida law against adulterating liquor with spices.

Business Consumers Health Science

Rampant Metal Contamination in Baby Food, House Investigation Finds

February 4, 2021February 4, 2021 SAMANTHA HAWKINS

babies, chemicals, FDA, food, labeling, nutrition, U.S. House of Representatives

Lawmakers say manufacturers exploited the lack of federal regulation to set dangerously high internal standards for toxic heavy metal levels.

Appeals Government Health

Justices Reinstate Medication Abortion Rule Lifted During Pandemic

January 12, 2021January 12, 2021 JACK RODGERS

abortion, FDA, regulation, Trump administration, U.S. Supreme Court

The Supreme Court on Tuesday granted the Trump administration ‘s request to reinstate a rule requiring women to visit a medical center to get an abortion drug, after a lower court lifted the regulation in light of the Covid-19 pandemic.

Health National Science

Biden to Release Almost All Covid-19 Vaccine Doses

January 8, 2021January 8, 2021 BRANDI BUCHMAN

coronavirus, FDA, pharmaceuticals, vaccines

Tabling concerns about second-dose supplies, the president-elect has a new strategy to combat the slow rollout of vaccines for the novel coronavirus under Trump.

Government Health

FDA Approves Second Covid-19 Vaccine

December 18, 2020December 18, 2020 BRANDI BUCHMAN

coronavirus, FDA

The Food and Drug Administration approved Moderna’s vaccine for Covid-19 Friday evening, making it the second vaccine authorized for use in the United States, a nation which continues to reel from the respiratory virus that has now killed over 310,000.

Government Health Science

FDA Advisers Recommend Emergency Authorization for Moderna Vaccine

December 17, 2020December 18, 2020 BRANDI BUCHMAN

coronavirus, FDA, vaccines

A second Covid-19 vaccine was recommended for emergency use by advisers to the Food and Drug Administration on Thursday, meaning distribution nationwide could start as soon as next week.

Government Health National

FDA Paves Way for Approval of Second Covid Vaccine

December 15, 2020December 15, 2020 BRANDI BUCHMAN

coronavirus, FDA, Research, vaccines

New findings on Moderna’s Covid-19 vaccine released Tuesday confirm its high efficacy rate and could lead to imminent approval for emergency use.

Government Health

States Will Start Getting Covid-19 Vaccine Monday, US Says

December 12, 2020December 14, 2020 ASSOCIATED PRESS

coronavirus, FDA, vaccines

The nation’s first COVID-19 vaccine will begin arriving in states Monday morning, U.S. officials said Saturday, after the government gave the final go-ahead to the shots needed to end an outbreak that has killed nearly 300,000 Americans.

Government Health National

FDA Panel Recommends Approval of Pfizer Virus Vaccine

December 10, 2020December 10, 2020 KAYLA GOGGIN

coronavirus, FDA, vaccines

A committee of advisers to the Food and Drug Administration voted Thursday to recommend Pfizer’s Covid-19 vaccine for emergency use nationwide to fight the pandemic that has killed nearly 300,000 Americans since March.

Courts Government Health

Covid Vaccine

December 9, 2020December 9, 2020 BRIEF

Centers for Disease Control and Prevention, coronavirus, FDA, FOIA, HHS, vaccines

The government watchdog group American Oversight sued the Trump administration Wednesday, claiming Health and Human Services, the Federal Drug Administration and the CDC have stonewalled its requests for communications with Pfizer about a coronavirus vaccine.

Government Health Science

FDA: Pfizer Vaccine Highly Effective After First Dose

December 8, 2020December 8, 2020 KAYLA GOGGIN

coronavirus, FDA, Research, vaccines

A detailed analysis released by the U.S. Food and Drug Administration on Tuesday verifies the safety and efficacy of a Covid-19 vaccine developed by Pfizer, two days before a meeting to recommend the vaccine for emergency use.

Business Government

E-Cigarette Regulation

December 3, 2020December 3, 2020 BRIEF

FDA, regulation, Tobacco

The D.C. Circuit affirmed the FDA’s ruling determining that e-cigarettes are “tobacco products” subject to regulation under the Family Smoking Prevention and Tobacco Control Act, over e-cigarette industry objections.

Health Science Technology

Moderna’s Covid Vaccine Is Next Up for FDA Consideration

November 30, 2020November 30, 2020 BRANDI BUCHMAN

coronavirus, FDA, pharmaceuticals, vaccines

Moderna is ready to seek emergency use authorization for the vaccine it has reported as over 94% effective in preventing Covid-19, the Massachusetts-based drugmaker said Monday.

Health Science

Study: Cancer-Causing Asbestos Lurking in Some Talc-Based Cosmetics

November 25, 2020November 25, 2020 MADELINE REYES

Asbestos, cosmetics, FDA, Research

Researchers who recently found asbestos in 15% of talc-based cosmetics samples analyzed in a small study say that current screening methods for the cancer-causing carcinogen are inadequate.

Business Criminal Health

OxyContin Maker Purdue Pharma Pleads Guilty to Federal Criminal Charges

November 24, 2020November 25, 2020 ERIKA WILLIAMS

conspiracy, FDA, Fraud, kickbacks, opioids, pharmaceuticals, pleas

Purdue Pharma pleaded guilty Tuesday to federal criminal charges related to the OxyContin manufacturer’s role in the nation’s deadly opioid crisis.

Business Government Health Science

Pfizer Says Its Covid Vaccine Is Ready for FDA’s Green Light

November 20, 2020November 20, 2020 BRANDI BUCHMAN

coronavirus, FDA, pharmaceuticals, vaccines

Pharmaceutical giant Pfizer and its partner BioNTech will forge ahead in their pursuit of emergency use authorization for their Covid-19 vaccine, a booster the company declared this week was 95% effective.

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