We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The FDA’s Center for Drug Evaluation and Research (CDER) yesterday released a Manual of Policies and Procedures (MAPP) document that spells out how the Office of Generic Drugs (OGD) will classify complex new drug products and drug-device combination products assigned to CDER. Read More
Two online pharmacies selling stimulant drugs were hit with warning letters from the FDA for unlawfully offering to distribute or dispense stimulants that are Schedule II controlled substances, including amphetamine drug products. Read More
The FDA has cited Clearfield, Utah-based Yusef Manufacturing Laboratories for significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals and deemed the company’s products adulterated. Read More
A $2.1 million gene therapy with the potential to cure beta-thalassemia, a lifelong blood disorder, is worth the price, according to the Institute for Clinical and Economic Review (ICER). Read More
The FDA’s Office of Prescription Drug Promotion (OPDP) has rapped Bausch Health for making false and misleading claims for its topical psoriasis treatment Duobrii. Read More
The FDA released revised final guidance for drug manufacturers, packers and distributors on submitting promotional materials in both electronic and nonelectronic formats. Read More
Vanda Pharmaceuticals is suing the FDA, claiming the agency refuses to disclose why it won’t approve the company’s sleep disorder drug Hetlioz (tasimeleton) for jet lag. Read More