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11 May 2024, 7:33 pm
The procedure was performed under a single FDA Expanded Access Protocol – known as compassionate use – granted to a single patient or group of patients with serious, life-threatening illnesses or conditions to gain access to experimental treatments or trials when no comparable treatment options or therapies exist. [read post]
10 May 2024, 9:05 pm
Klein notes that DTC pharmaceutical companies have avoided FDA advertising regulations in part by labeling themselves as entities over which FDA has no regulatory authority. [read post]
10 May 2024, 8:17 am
The FDA instead asked that Congress provide instructions as to the rules that should be adopted in these areas (see FDA announcement here). [read post]
10 May 2024, 6:39 am
… The FDA explains that at-home ovulation urine tests measure LH to detect ovulation and are successful at doing so “reliably about 9 times out of 10[.] [read post]
10 May 2024, 5:10 am
In 2004, the FDA approved a change in the Reglan label as applied for by the owner of its NDA. [read post]
10 May 2024, 4:36 am
Tradewind Foods de Puerto Rico Inc. of Bayamon, PR is recalling Goya Red Kidney Beans after an FDA Inspection discovered swollen and leaking cans. [read post]
9 May 2024, 10:55 am
Food and Drug Administration (FDA) discovered that samples of the drug contained N-nitrosodimethylamine (NDMA), a substance classified as a probable human carcinogen. [read post]
8 May 2024, 9:05 pm
” The letters seek a food safety line item in the FDA’s fiscal year 2025 appropriation. [read post]
8 May 2024, 9:02 pm
Use link above to go to FDA page with links to specific alerts. [read post]
8 May 2024, 11:18 am
The post Biotech CEL-SCI gets FDA go-ahead to conduct investigational cancer immunotherapy study appeared first on Maryland Daily Record. [read post]
8 May 2024, 10:10 am
The program began in 2018 when FDA issued an order granting an alternative reporting approach under 21 CFR 803.19. [read post]
8 May 2024, 9:00 am
The post Understanding the Different Types of Nursing Jobs and Corresponding Compliance Issues – Part Three appeared first on Cohen Healthcare Law Group | Healthcare Lawyers | FDA & FTC Law. [read post]
8 May 2024, 4:10 am
” The process has never been FDA approved, and researchers and major medical professional associations in the United States and abroad, including the American College of Obstetricians and Gynecologists (“ACOG”), have warned that it is unproven and unscientific. [read post]
7 May 2024, 9:05 pm
FDA responded by warning consumers to avoid all raw milk products. [read post]
7 May 2024, 11:22 am
Food and Drug Administration (FDA) are collecting different types of data to investigate a multistate outbreak of Salmonella Typhimurium infections. [read post]
7 May 2024, 5:57 am
According to the details posted online by the Food and Drugs Administration (FDA), the recall was initiated on April 16, 2024, and is ongoing. [read post]
7 May 2024, 2:00 am
Reports can be made through MedWatch, which is the adverse event reporting program the FDA operates. [read post]
6 May 2024, 6:48 pm
FDA provides examples of changes that are likely and unlikely to impact cybersecurity of an existing device. [read post]
6 May 2024, 8:26 am
Maybe they said more to the FDA? [read post]
5 May 2024, 10:00 pm
The US Food and Drug Administration (FDA) on April 29, 2024 announced its Final Rule on laboratory-developed tests (LDTs). [read post]
