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Over-the-counter (OTC) drug manufacturer Midlab of Athens, Tenn., was slapped with a six-observation FDA Form 483 for failing to validate its drug manufacturing processes and equipment and its water system, in addition to using expired raw materials. Read More
To clear up any confusion about what the FDA considers delaying, denying, limiting, or refusing a drug or device inspection, the agency released a draft guidance on Thursday. Read More
Vanda Pharmaceuticals has vowed to appeal a federal judge’s dismissal of several patent infringement claims aimed at Teva Pharmaceuticals and Apotex over their generic forms of its sleep disorder drug Hetlioz (tasimelteon). Read More
The FDA has revised a guidance issued in July on failure to respond to a Complete Response Letter (CRL) from the agency for an abbreviated new drug application (ANDA), updating it to include commitments it made for reauthorization of the Generic Drug User Fee Amendments (GDUFA III). Read More
Under the terms of the agreement, the methods that will come out of this partnership will be made available to other domestic generics manufacturers. Read More
Centrient Pharmaceuticals’ active pharmaceutical ingredient (API) facility in Punjab, India, received a warning letter from the FDA for multiple deficiencies including lax records, test validations and inadequate contaminant controls. Read More
The FDA says a single, well-controlled trial may be used to support a drug candidate for treatment of pulmonary tuberculosis (TB) if additional confirmatory evidence is available, in a revised draft guidance released yesterday. Read More
The Biden Administration will seek a change in the coverage of generic medicines in plans offered through the Affordable Care Act (ACA) marketplace, according to a notice issued by HHS. Read More