WASHINGTON — The Consumer Healthcare Products Association (CHPA) issued the following statement from Marcia Howard, vice president, Scientific and Regulatory Affairs, upon the U.S. Food and Drug Administration (FDA) issuance of a Proposed Rule and Draft Guidance for establishing a regulatory category for over-the-counter (OTC) hearing aids: “CHPA applauds FDA for issuing this long-awaited proposed rule which
WASHINGTON — According to published reports, the Food and Drug Administration will soon allow Americans to receive a booster shot of COVID-19 vaccine different from their original dose. The federal drug regulator is expected to announce the so-called “mix and match” strategy on Wednesday when it officially authorizes boosters of the two-dose Moderna and single-shot
WASHINGTON — The U.S. Food and Drug Administration on Wednesday authorized a booster dose of the Pfizer and BioNTech COVID-19 vaccine for those 65 and older, all people at high risk of severe disease, and others who are regularly exposed to the virus. The decision paves the way for a quick rollout of the booster
WASHINGTON — A U.S. Food and Drug Administration advisory committee on Friday voted to reject COVID-19 vaccine booster shots for most Americans, but authorized them for people 65 and over and those who are at high risk for severe COVID-19. The votes came amid division among scientists inside and outside the FDA as to whether
WASHINGTON — The Food and Drug Administration reported on Monday that it has granted full approval to Pfizer and BioNTech for their COVID-19 vaccine to be given to Americans as young as 16, clearing the way for a wave of moves that health officials say could reverse a nationwide slowdown in the pace of first
NEW YORK— According to published reports, the Food and Drug Administration is expected to approve COVID-19 vaccine booster shots this week. The FDA amendment of the emergency use authorizations for the Pfizer and Modern vaccines would allow anyone with compromised immune systems to get a third dose. The move, which could come as early as today, comes after
Editor’s note: The National Association of Chain Drug Stores (NACDS) published the following article on their website on the Food and Drug Administration (FDA) approval Semglee as the first interchangeable biosimilar product: In an historic move last week, the Food and Drug Administration (FDA) approved Semglee (insulin glargine-yfgn) as the first interchangeable biosimilar product. With this approval,
WASHINGTON — Following a thorough safety review, including two meetings of the CDC’s Advisory Committee on Immunization Practices, the U.S. Food and Drug Administration and the U.S. Centers for Disease Control and Prevention have determined that the recommended pause regarding the use of the Johnson & Johnson (Janssen) COVID-19 Vaccine in the U.S. should be
WASHINGTON — On Tuesday both the Food and Drug Administration and Centers for Disease Control and Prevention are recommending a “pause” in the administration of Johnson & Johnson’s single-dose COVID-19 vaccine to review blood clot cases. The agencies announced in a statement that the CDC will convene a meeting of the Advisory Committee on Immunization Practices
SOUTH SAN FRANCISCO, Calif.— Genentech announced that the U.S. Food and Drug Administration (FDA) has approved the company’s supplemental Biologics License Application for Xolair (omalizumab) prefilled syringe for self-injection across all approved U.S. indications. Xolair is the only FDA-approved biologic designed to target and block immunoglobulin E (IgE) for the treatment of moderate to severe
ARLINGTON, Va. – FMI – The Food Industry Association released on Thursday the following statement from chief food and product safety officer Hilary Thesmar, regarding the U.S. Food and Drug Administration’s (FDA) release of a comprehensive plan to outline how the agency will approach heavy metal action levels in baby food. Dr. Thesmar said: “As the
WASHINGTON — The Food and Drug Administration advisory committee endorsed Johnson & Johnson’s coronavirus vaccine late Friday afternoon, with panel members saying the shot will be a crucial third option to vaccinate millions of Americans. The vaccine appears widely effective against the virus and is especially good at preventing severe cases, according to data presented
WASHINGTON— Dr. Janet Woodcock, who has led the Food and Drug Administration’s drug review efforts for years, has been tapped to lead the agency on an interim basis after current Commissioner Stephen Hahn leaves office today. President-elect Joe Biden has yet to nominate an FDA commissioner. Dr. Hahn has designated Dr. Woodcock as interim commissioner
WASHINGTON — The Food and Drug Administration formally authorized a second vaccine for emergency use from Moderna. The biotech upstart won authorization for use in adults following extensive federal analysis of the vaccine, which the FDA found to be 94% effective at preventing the disease. “With the availability of two vaccines now for the prevention of
