The FDA released guidance on the International Council for Harmonization’s good clinical practice guidelines and its addendum on advances in clinical trial design. Source: Drug Industry Daily

In its first ever annual report, the Office of Pharmaceutical Quality highlighted its main accomplishments in 2017 and noted it faced major challenges with more than 100 of its 1,300…

Commenting on FDA’s planned patient-focused drug development guidance, industry stakeholders said the agency needs to clarify how it will incorporate patient experience data into specific stages of development. Source: Drug…

The FDA hit Indian API manufacturer Alchymars ICM SM with a warning letter after an investigation found the firm falsified laboratory data, failed to thoroughly investigate complaints and improperly maintained…

More states have aligned their oversight of drug compounding with federal standards in the last two years even though some states dropped inspections, according to an analysis by the Pew…

Researchers at the FDA and the Centers for Medicare and Medicaid Services are considering whether a cell-based influenza vaccine might be more effective than the egg-based vaccine that did not…

The Justice Department is creating a task force to combat the opioid crisis and plans to file a Statement of Interest in multidistrict litigation against distributors and manufacturers of opioids,…

The FDA issued A&Z Pharmaceutical a Form 483 for deficiencies at its Hauppauge, New York facility that included improper storage conditions, poor calibration practices and failure to review batch failures.…

The U.S. Department of Justice filed a complaint against Patient Care America, a Pompano Beach, Florida compounding pharmacy, claiming the firm made illegal payments to secure prescriptions for drugs reimbursed…

In another blow to Allergan’s efforts to retain exclusivity for its dry-eye drug Restasis, the U.S. Patent Trials and Appeals Board said Allergan’s transfer of the patents to the St.…