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10 Oct 2017, 7:30 am
Food and Drug Administration (FDA) as a treatment for patients with advanced nonsquamous non-small cell lung cancer (NSCLC). [read post]
20 Nov 2014, 4:04 am
The OIG has released its compilation of “2014 Top Management & Performance Challenges,” highlighting the following 10 most significant management and performance challenges now facing HHS: Implementing, Operating, and Overseeing the Health Insurance Marketplaces Ensuring Appropriate Use of Prescription Drugs in Medicare and Medicaid Protecting an Expanding Medicaid Program from Fraud, Waste, and Abuse Fighting Waste and Fraud and Promoting Value… [read post]
24 Feb 2023, 9:15 am
Court of Appeals for the Federal Circuit (CAFC) issues a precedential decision affirming a district court’s order that Jazz Pharmaceuticals must delist its patent related to the narcolepsy drug Xyrem from the Food and Drug Administration’s (FDA’s) Orange Book; the U.S. [read post]
31 Jan 2024, 1:15 pm
In a recent brief to the Patent Trial and Appeal Board (PTAB), Pfizer and BioNTech (Pfizer) told PTAB judges that Moderna’s dismissal of prior art listed in Pfizer’s August 2023 petition for inter partes review (IPR) of Moderna’s patent on mRNA vaccine technology is inconsistent with its declarations to the Food and Drug Administration (FDA) during the drug approval process. [read post]
29 May 2013, 3:03 pm
Health officials are investigating cases involving patients who suffered complications after being injected with potentially contaminated medications made by a Tennessee specialty pharmacy.The Food and Drug Administration said Friday the problems involve seven patients who received steroid injections from Main Street Family Pharmacy, a compounding pharmacy in Newbern, Tenn.Tennessee health officials said the pharmacy has agreed to recall all of its sterile products,… [read post]
14 Dec 2022, 4:15 am
he United States Patent and Trademark Office (USPTO) sent out a reminder today to those interested in speaking at an upcoming Public Listening Session on collaboration efforts between the USPTO and Food and Drug Administration (FDA) that they must sign up to participate by January 5, 2023. [read post]
16 Jun 2013, 4:29 pm
Food and Drug Administration said Thursday, providing the first direct evidence that the pharmacy is responsible for a new outbreak involving a widely used steroid medication.So far, methylprednisolone acetate from the Newbern, Tenn., pharmacy has sickened 24 people in Illinois, North Carolina, Florida and Arkansas. [read post]
24 Feb 2023, 9:15 am
Court of Appeals for the Federal Circuit (CAFC) issues a precedential decision affirming a district court’s order that Jazz Pharmaceuticals must delist its patent related to the narcolepsy drug Xyrem from the Food and Drug Administration’s (FDA’s) Orange Book; the U.S. [read post]
8 Mar 2014, 4:28 pm
Food and Drug Administration officials said this week that lots of the supplement L-citrulline sold by the compounding firm Medisca were found not to contain the drug at all. [read post]
25 Mar 2020, 4:15 am
The Sanofi decision provides a possible opportunity to seek antitrust liability against brand companies for abusing Food and Drug Administration (FDA) regulations. [read post]
4 Oct 2019, 6:55 am
Food and Drug Administration (FDA), on September 30, 2019, announced the availability of a draft guidance for industry (GFI) #171 titled “Demonstrating Bioequivalence for Soluble Powder Oral Dosage Form Products and Type A Medicated Articles Manufactured from Active Pharmaceutical Ingredients Considered to be Soluble in Aqueous Media. [read post]
27 Dec 2023, 9:48 pm
Food and Drug Administration announced approval of Amgen's Wezlana (ustekinumab-auub) as an interchangeable biosimilar to Janssen Biotech's Stelara (ustekinumab). [read post]
6 Aug 2020, 1:15 pm
The latest exhibit—in the intellectual property space at least—is a letter to Health and Human Services (HHS) Secretary Azar, National Institutes of Health (NIH) Director Collins and Food and Drug Administration (FDA) Commissioner Hahn authored by California Attorney General Xavier Becerra and Louisiana Attorney General Jeff Landry. [read post]
25 Nov 2012, 6:07 pm
Food and Drug Administration (FDA) has required the maker of NuvaRing to more specifically outline the risks of this potentially dangerous drug. [read post]
31 Jan 2024, 1:15 pm
In a recent brief to the Patent Trial and Appeal Board (PTAB), Pfizer and BioNTech (Pfizer) told PTAB judges that Moderna’s dismissal of prior art listed in Pfizer’s August 2023 petition for inter partes review (IPR) of Moderna’s patent on mRNA vaccine technology is inconsistent with its declarations to the Food and Drug Administration (FDA) during the drug approval process. [read post]
15 Oct 2023, 9:38 pm
Food and Drug Administration announced approval of Biogen's Tofidence® (tocilizumab-bavi) as a biosimilar to Genentech's Actemra®, a drug approved for treating COVID-19, rheumatoid arthritis, giant cell arteritis, scleroderma, polyarticular or systemic juvenile idiopathic arthritis, and severe cytokine release syndrome. [read post]
14 Dec 2022, 4:15 am
he United States Patent and Trademark Office (USPTO) sent out a reminder today to those interested in speaking at an upcoming Public Listening Session on collaboration efforts between the USPTO and Food and Drug Administration (FDA) that they must sign up to participate by January 5, 2023. [read post]
3 Dec 2013, 12:04 am
Both GranuFlo and NaturaLyte were subject to a Class I Recall after serious risks arose and the Food and Drug Administration (FDA) became concerned about the link between GranuFlo/NaturaLyte and patients suffering cardiac arrest. [read post]
5 Aug 2021, 8:43 am
United States Food and Drug Administration. [read post]
25 Jul 2022, 9:15 am
Food and Drug Administration. [read post]
