Breast implant maker Allergan issued a worldwide recall for certain textured models after the FDA alerted the company to heightened cancer risk with the devices. The U.S. Food and Drug Administration (FDA) announced that... Read More
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FDA clears app to help cancer patients self-manage…
August 5, 2019Voluntis received marketing authorization from the FDA for its digital app to aid patients suffering from different types of cancer. The mobile app, called Oleena, is designed to provide users with real-time, adaptive re... Read More
The guidance issued by the US Food and Drug Administration (FDA) explains how combination product manufacturers should comply with post-market safety reporting requirements which were originally established in 2016. It w... Read More
With growing concerns among consumers about the health risks involved in consuming meat and animal welfare, the FDA has approved a key ingredient Impossible Food uses to make its burgers look and “bleed” like real me... Read More
FDA Targets CBD Giant Over Marketing Concerns
August 1, 2019The FDA has sent a pointed warning letter to Curaleaf Holdings Inc., a seller of cannabidiol (CBD) products, for not following the regulating body’s labeling guidelines. The FDA called out two marketing strategies whic... Read More
Dr.Reddy’s Warning Letter Woes Continue
August 1, 2019Dr. Reddy’s is expecting an inspection of its Active Pharmaceutical Ingredient (API) plant at Srikakulam by the Food and Drug Administration (FDA) later this year. “In March 2019, we responded to the follow-up qu... Read More
FDA clears new tests for the diagnosis of…
July 31, 2019The FDA has approved the marketing of four tests with new indications for the diagnosis of Lyme disease. These are previously cleared tests from ZEUS ELISA. The laboratory diagnosis of Lyme disease is a two-tier process... Read More
Indoco Remedies Receives EIR from FDA for two…
July 30, 2019Indoco Remedies received Establishment Inspection Report (EIR) for its sterile facility and solid dosage facility in Verna, Goa. The inspection was conducted from May 27 to June 4, 2019 and resulted in four observations... Read More
La Jolla Pharmaceutical Company has been granted Orphan Drug Designation for the Investigational Drug Product, LJPC-0118, for the treatment of severe cases of malaria. The Active Pharmaceutical Ingredient (API) is... Read More
Dr. Reddy’s launches new tablet to treat Insomnia…
July 25, 2019Dr. Reddy’s has launched a new generic tablet called Ramelteon, 8 mg in the US market after approval by the Food and Drug Administration (FDA). It is a generic drug which is therapeutically equivalent to the Takeda Pha... Read More
The FDA takes its fight against e-cigarette use…
July 24, 2019The FDA recently announced the launch of TV ads as part of its “The Real Cost” Youth E-Cigarette Prevention Campaign to discourage the use of e-cigarettes among teens nationwide. They also plan to distribute po... Read More
Indian drugmaker Strides receives warning letter by the…
July 23, 2019Strides Pharma Science Ltd has come under the line of fire of the FDA after an investigator found evidence of adulteration and uncontrolled shredding of documents in its Puducherry plant in India. It has seven manufactur... Read More
Federal Judge enters consent decree with J and…
July 22, 2019J and L Grocery of Alma, Arkansas was ordered by the U.S. District Court to cease distribution of all its products, namely food, drugs, medical devices, and cosmetics. The reason for such a measure was the insanitary con... Read More
Biocon faces a new hurdle with the FDA…
July 19, 2019The inspection conducted by the US Food and Drug Administration (FDA) on the Malaysian Insulin Facilities of leading biotechnology giant Biocon resulted with a Form 483. The US regulating body has issued 12 observations... Read More