Quality/GMPs

Commissioner Gottlieb is reorganizing FDA in the hopes of streamlining policymaking.

Rising pressure to do more to control drug prices is prompting Trump administration officials to explore where more flexible import policies may help ensure access to safe, effective, and more affordable medicines.

The agency announced two research collaborations on bulk lists, updates to categories of bulk drug substances, and issued a warning about a bulk drug substance used in compounding.

FDA and ICH seek comment on new exposure levels for cadmium in drug products.

Inspectors found quality issues at bB BioChem Laboratories Inc, a California-based manufacturer of over-the-counter drug products.

FDA Commissioner, Scott Gottlieb, announced formation of a new, drug shortages task force and efforts to advance long-term solutions to prevent shortages.

Teva Pharmaceuticals, Major Pharmaceuticals, and Solco Healthcare are voluntarily recalling their products containing valsartan because of the presence of N-nitrosodimethylamine.

The agency is releasing six new draft guidances to provide a regulatory framework for handling gene therapies.

The European Medicines Agency recommended Novartis’ Kymriah (tisagenlecleucel) and Kite’s Yescarta (axicabtagene ciloleucel), chimeric antigen receptor (CAR) T-cell therapies, for approval in the European Union.

The agency is asking firms to discuss internal quality metrics efforts as part of the approval process for new medical products.

Legislators look to widen access to medications for addiction treatment and overdose emergencies.

The company’s new LCMS-9030 system is designed for high resolution and accurate mass detection.

The company unveiled its latest innovations to its mass spectrometry portfolio at ASMS in San Diego.

The European Directorate for the Quality of Medicines & Healthcare highlighted the organization’s achievements in 2017, including the first mAb monograph.

Fagron Sterile Services is voluntarily recalling two lots of Neostigmine Methylsulfate 5mL syringes due to mislabeling.

Knowing and addressing regulatory expectations early on can avoid unexpected delays later, says Siegfried Schmitt, principal consultant at PAREXEL.

Biopharma companies can balance competing demands from patients, investors, and regulators by keeping a focus on science.

FDA seeks more efficient testing to spur development of less costly biotech therapies.

Quality experts share insights on what the future may hold regarding regulatory quality requirements for biopharmaceuticals.

BioPharm International asked an FDA spokesperson how the agency plans on handling these issues in the future.

Increasing demand for biologics is driving the need for innovation in bioprocessing.

Late-stage and commercial biomanufacturing pose a challenge to cell-culture processing.

Biosimilars and biobetters face developmental challenges to achieving commercialization.

The new resin used a combination of “jetting” technology and a high-performance Protein A ligand.

FDA sent a warning letter to Henan Lihua Pharmaceutical Co. Ltd. after inspectors found the company failed to ensure the accuracy of its data.

The company’s next-generation ultraperformance liquid chromatography platform is designed to meet the evolving laboratory requirements for chromatographic performance.

GW Research’s Epidiolex, which treats two forms of epilepsy, receives FDA’s approval; spurs FDA reminders about unapproved products.

The agency published guidance about requests for Prescription Drug User Fee Act waivers, refunds, and reductions in user fees.

The agency launched a secure online portal for orphan drug designation applications.

FDA, EMA, and senior officials from the European Commission met to discuss the EU-US mutual recognition agreement for inspections, the development of advanced therapies, the requirements for approving generic drugs, and Real-World Evidence used for post-authorization monitoring.