FDA

Supreme Court Allows Government to Enforce Abortion Pill Rule
Supreme Court
Supreme Court Allows Government to Enforce Abortion Pill Rule
2021-01-13 16:39:53
by Dan McCue

WASHINGTON - The U.S. Supreme Court lifted a nationwide injunction Tuesday that had prevented the federal government from enforcing a rule that required women to see a health care professional in person before she'd be given access to a so-called... Read More

EXPLAINER: US Regulator Weighs in on Vaccine Dosing Debate
Health
EXPLAINER: US Regulator Weighs in on Vaccine Dosing Debate

The first Americans vaccinated against COVID-19 are getting their second dose, while Britain has decided to postpone boosters and focus instead on giving more people a first shot — international differences that are adding to public confusion. There's growing debate... Read More

2nd COVID-19 Vaccine Set for OK in US With Panel Endorsement
Health
2nd COVID-19 Vaccine Set for OK in US With Panel Endorsement

WASHINGTON (AP) — A government advisory panel endorsed a second COVID-19 vaccine Thursday, paving the way for the shot to be added to the U.S. vaccination campaign. The Food and Drug Administration is expected to follow the recommendation for the... Read More

FDA Clears First At-Home, Over-The-Counter COVID-19 Test
Health
FDA Clears First At-Home, Over-The-Counter COVID-19 Test

WASHINGTON — The first COVID-19 test that can be performed entirely from home was cleared by U.S. regulators on Tuesday, and it can be acquired without a prescription. While availability initially will be limited, the new test and others in... Read More

Moderna Vaccine Found Safe, Effective Ahead of Key FDA Review
Health
Moderna Vaccine Found Safe, Effective Ahead of Key FDA Review

Moderna Inc.’s vaccine is safe and effective for preventing COVID-19, U.S. regulators said, clearing the way for a second shot to quickly gain emergency authorization and add to the country’s sprawling immunization effort. The Food and Drug Administration’s staff said... Read More

FDA Issues Emergency Approval for Pfizer Vaccine, Others Sure to Follow
Health
FDA Issues Emergency Approval for Pfizer Vaccine, Others Sure to Follow
2020-12-11 21:19:29
by Dan McCue

WASHINGTON - Under intense pressure from the White House, the Food and Drug Administration dramatically moved up its timeline, issuing an emergency authorization for Pfizer's COVID-19 vaccine on Friday. The agency had initially planned to finalize its authorization on Saturday,... Read More

FDA Approves Gilead's Remdesivir as Coronavirus Treatment
Health
FDA Approves Gilead's Remdesivir as Coronavirus Treatment

The U.S. Food and Drug Administration has officially approved remdesivir as a treatment for coronavirus, drug manufacturer Gilead Sciences announced Thursday. The Ebola drug was already being used to treat patients under an emergency-use authorization issued in May, but the latest FDA action makes... Read More

FDA Releases High Coronavirus Vaccine Standards Despite White House Resistance
Health
FDA Releases High Coronavirus Vaccine Standards Despite White House Resistance

WASHINGTON — The Food and Drug Administration issued long-awaited guidance Tuesday on the data it expects from drug companies seeking emergency authorization of COVID-19 vaccines, rejecting White House pressure for lower standards intended to push out vaccines quickly. The 18-page... Read More

Fauci to FDA: ‘I Got Your Back’ on COVID-19 Vaccine Safety Standards
Health
Fauci to FDA: ‘I Got Your Back’ on COVID-19 Vaccine Safety Standards

ATLANTA — The federal government’s top infectious disease official attempted to reassure the public Thursday that he’ll support safety standards set by federal officials for any COVID-19 vaccines and their work won’t be swayed by politics. “If (U.S. Food and... Read More

At Philip Morris International Smoke-free Future Cornerstone of Sustainability
Innovation
At Philip Morris International Smoke-free Future Cornerstone of Sustainability
2020-07-24 17:26:29
by Dan McCue

WASHINGTON - It has been an eventful summer for Philip Morris International, the company perhaps best known for its Marlboro and Chesterfield cigarette brands. First, Chief Executive Officer André Calantzopoulos declared in the company’s recently released integrated report that he... Read More

FDA Issues Draft Guidance on Cannabis Research
In The News
FDA Issues Draft Guidance on Cannabis Research
2020-07-22 12:43:42
by Dan McCue

WASHINGTON - The Food and Drug Administration issued a draft guidance establishing rules for lawfully researching cannabis. The guidance is limited to the development of drugs and does not cover other FDA-regulated products. Nevertheless, the release of the document and... Read More

FDA Asks Judge to Delay E-Cigarette Deadline, Citing Virus
Courts
FDA Asks Judge to Delay E-Cigarette Deadline, Citing Virus

WASHINGTON — The Food and Drug Administration asked a federal judge to grant a 120-day delay for a deadline for e-cigarette manufacturers to submit applications to keep their products on the market. Citing “the exceptional circumstances presented by the global... Read More

Straight From The Well
scroll top