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26 Feb 2024, 2:26 am
§ 314.3, codified in 2016, which defines strength as the “total quantity of drug substance in mass or units of activity in a dosage unit or container closure” and/or “the concentration of the drug substance. [read post]
14 Dec 2019, 10:06 pm
US Food and Drug Administration, October 24, 2018. [read post]
28 Apr 2022, 9:02 pm
Food and Drug Administration (FDA) announced it will propose a rule that would ban the sale of menthol-flavored cigarettes. [read post]
29 Oct 2018, 9:04 pm
While the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) conducted the official investigation, an LGMA task force also spent two months looking to find the cause of the 2018 E. coli outbreak. [read post]
4 Apr 2009, 10:30 pm
Whenever the Food and Drug Administration (FDA) approves a drug for sale, it means that the manufacturer has submitted a report of a study showing that the number of people who had beneficial results at certain dosages was greater than the number of people who suffered harmful side effects with permanent damage or death. [read post]
11 Oct 2018, 9:30 pm
Food and Drug Administration (FDA) revoked its approval of six synthetic food additives in response to a petition from several organizations. [read post]
5 Mar 2021, 9:03 pm
Food and Drug Administration (FDA) just approved a new single-dose vaccine from Johnson & Johnson for an emergency use authorization (EUA) at the end of February. [read post]
22 Jul 2021, 6:40 am
The United States Food and Drug Administration (FDA) has a database, called the FDA Adverse Events Reporting System (FAERS), that records voluntary reports by patients and physicians concerning complications with a drug or medical device. [read post]
5 Dec 2016, 7:20 am
The reason for this is because the United States Food and Drug Administration (FDA) approved testosterone hormone for patients who have a medical condition known as hypogonadism. [read post]
22 Jul 2021, 6:40 am
The United States Food and Drug Administration (FDA) has a database, called the FDA Adverse Events Reporting System (FAERS), that records voluntary reports by patients and physicians concerning complications with a drug or medical device. [read post]
22 Jul 2021, 6:40 am
The United States Food and Drug Administration (FDA) has a database, called the FDA Adverse Events Reporting System (FAERS), that records voluntary reports by patients and physicians concerning complications with a drug or medical device. [read post]
11 Aug 2016, 7:39 am
In fact, this was the only medical condition for testosterone hormone was approved by the United States Food and Drug Administration (FDA), and still remains the only approved use. [read post]
5 Dec 2016, 7:20 am
The reason for this is because the United States Food and Drug Administration (FDA) approved testosterone hormone for patients who have a medical condition known as hypogonadism. [read post]
9 Sep 2024, 8:07 am
Food and Drug Administration (FDA) regulation has slowed adoption and increased costs for tests and devices that inform patients about their own bodies. [read post]
17 Nov 2017, 9:00 pm
The business appears to have continued operating, according to a notice from the U.S Food and Drug Administration on Friday evening. [read post]
27 Apr 2017, 1:30 am
Kline School of Law, Taming Pharma with Benefit CorporationsDmitry Karshtedt, The George Washington University Law School, Regulating ‘Evergreening’: The FDA's Role in the Creation of Balanced Rights for Pharmaceutical ImprovementsMichael Sinha, Brigham and Women's Hospital and Harvard Medical School, Legal Approaches to Ensuring Timely Generic Drug AvailabilityRebecca Wolitz, Stanford Law School, Patents, Preemption, and Price-Gouging Teaching Session 1G – Room… [read post]
6 May 2020, 4:51 pm
Food and Drug Administration (“FDA”) approval process that are indicated to treat moderate to severe Crohn’s disease and ulcerative colitis. [read post]
6 Feb 2012, 7:18 am
Food & Drug Administration (FDA) issued a warning about the popular diabetes drug Actos(pioglitazone). [read post]
25 Jan 2012, 9:57 am
Moreover, the patent office [ie the United States Patent and Trademark Office] isn't equipped to judge therapeutic benefit'.Instead, Dr Torreele proposes a more stringent approach so that new medicines had to demonstrate 'a therapeutic benefit over existing treatments before giving market approval—a judgment the agency [the Food and Drug Administration in the United States] is perfectly capable of making, but somehow… [read post]
8 Apr 2021, 9:03 pm
Food and Drug Administration (FDA) approved Qelbree, a new drug for attention-deficit hyperactivity disorder (ADHD), for children aged 6 to 17. [read post]
