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 it called for the removal after new information showed Allergan’s Biocell breast implants with a... Read More
Voluntis 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 recommendations to help them manage their symptoms on a daily basis. Combined with remote patient monitoring... 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 was supposed to be issued in 2018 but got delayed by almost a year. The guidance elaborates on the... 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 meat. Soy leghemoglobin, a protein-based color additive which is found in the root nodules... Read More
The 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 which it found troubling. It stated that the company tried to market CBD products as a... Read More
Dr. 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 questions from USFDA regarding the API facility in Srikakulam. Based on the subsequent discussion with USFDA,... Read More
The 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 in which a protein test called Western Blot is conducted after the initial... Read More
Indoco 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 of Form 483. This was mentioned to Bombay Stock Exchange (BSE) in a filing. “We... 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 artesunate. Artesunate demonstrated superiority over quinine in reducing the mortality rates of patients suffering from severe falciparum malaria infection.... Read More
Dr. 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 Pharmaceutical Company’s Rozerem tablets of the same strength, Dr. Reddy’s said in... Read More
The 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 posters to high schools and educational materials to middle schools to drive home the message.... Read More
Strides 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 manufacturing plants spread across three continents. The lack of a proper quality unit is... Read More
J 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 conditions prevalent in and around its seven warehouses used to store FDA-regulated... Read More
The 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 that fall under the category of ‘objectionable conditions’ prevalent during the inspection. Biocon in partnership... Read More