Quality/GMPs

The agency sent out 13 warning letters on Sept. 19, 2017 to companies selling drug products online.

Validation and batch testing failures were among the violations found by the FDA at the company’s Jiangsu facility.

Continued industry investment in advanced biologics will raise further regulatory challenges and require innovative manufacturing systems.

The approval marks the first biosimilar approved in the United States for treating cancers.

European Medicines Agency’s Committee for Medicinal Products for Human Use grants a positive opinion for the approval of the biosimilar for treating breast cancer.

Along with particulate control and determination, speakers at the June conference in Rockville, Maryland, examined the role of protein aggregation and immunogenicity

The agency is looking for industry input on best practices for continuous manufacturing.

FDA works with industry on strategies for assuring high-quality regenerative medicines.

The differences between the quality control and quality assurance units can be found in their names, according to Siegfried Schmitt, principal consultant at PAREXEL.

A new collaboration between CDER and ORA will more fully integrate drug review programs with facility evaluations and inspections, in an effort to streamline drug reviews while strengthening manufacturing oversight.

FDA has put out an alert regarding the risks associated with using Keytruda in combination with other anti-cancer drugs based on interim results from two clinical trials that showed increased risk of death.

Faced with divisive political and social issues, Congress must find a way to reach consensus.

The control of biologics microbiological impurities, contaminants, and mimetics is evolving.

Protecting against microbiological contaminationover the whole manufacturing process grows increasingly important.

FDA issued a Refusal to File letter to Acorda Therapeutics, citing insufficiently complete information in the company’s new drug application for its investigational Parkinson’s disease drug.

An FDA evaluation concluded that Corden Pharma Latina’s corrective actions addressed the concerns in an FDA warning letter.

High-priority issues requiring immediate attention leave little time for Congress to consider drug access proposals that have limited bipartisan support.

FDA issues a statement on new policy and enforcement steps to ensure proper oversight of stem cell therapies and regenerative medicine in the wake of two incidents involving unauthorized stem-cell treatment activity.

Laboratory tests can determine critical cleaning parameters for passivation treatments used to prevent rouge on GMP stainless-steel equipment.

The company is voluntarily recalling the products because of potential contamination with Burkholderia cepacia.

The US Pharmacopeial Convention is hosting a variety of workshops in Autumn 2017 on a wide range of topics including continuing education, bioassays, and peptides.

FDA has signed a confidentiality commitment with the European Commission and the European Medicines Agency that allows FDA to share confidential information with EU regulations.

FDA sent a warning letter to Bicooya Cosmetics Limited after inspectors found rodent feces at the company’s Zhejiang, China facility.

The directors of FDA’s Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, and Center for Devices and Radiological Health praised Congress’ reauthorization of user fee programs.

The agency published guidance on identifying trading partners under DSCSA.

The withdrawal has been attributed to issues at the biotech company’s manufacturing facility.

The company is voluntarily recalling Lorazepam Oral Concentrate, USP 2mg/mL because of misprinted dosing droppers.

A pilot program will offer instruction on scientific and regulatory guidelines including training on GMPs and quality.

The agency sent a warning letter to Cellex-C International regarding GMP violations found at the company’s Toronto facility.

Efforts to establish an international system for identifying and tracing drugs through the global supply chain are moving forward.