Regulatory Oversight and Compliance

The agency published four guidance documents regarding ANDAs and amendments to ANDAs.

The European Commission is striving to tackle environmental pollution by pharmaceuticals as a means of curbing antimicrobial resistance.

Industry and FDA face new fee structures and new challenges in implementing fee initiatives.

Focusing on whether the product meets its defined quality attributes should help one make reasonable, documentable, and defendable risk-based decisions, according to Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.

Just as FDA strengthens ties between reviewers and plant inspectors, proactive manufacturers are involving different disciplines in preparation for FDA audits.

The draft guidance gives recommendations for reproductive toxicity testing and labeling.

FDA sent a warning letter to Shandong Vianor Biotech Co., Ltd. that claimed the company failed to follow proper data integrity and quality control procedures.

The agency will require training for healthcare providers who prescribe immediate-release opioids.

The FDA commissioner made a statement about the agency’s efforts to ensure patient access to safe compounded medicines.

Staff survey on the relocation of EMA indicates that the future of public health in Europe is at stake.

Pharmaceutical companies should prepare for the impact of recalls to minimize risk to consumers and the company.

Biopharmaceutical companies developing new competitive biotech therapies have pressed hard for clarity on the testing and data required by FDA to gain market approval of biosimilars that can be filled by a pharmacist without prescriber preapproval.

FDA participated in a global operation to combat the sale and distribution of unapproved and illegal drugs.

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.

The meeting, to be held jointly with the European Centre for Disease Prevention and Control, is part of the agency’s effort to raise awareness about the threat of antimicrobial resistance.

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

FDA cited Meridian Medical Technologies, a Pfizer company, which manufactures Mylan’s EpiPen, for cGMP violations that included failure to appropriately investigate defects in auto-injector components.

Six years after the guidance, it’s time to change our quality assurance vocabulary.

Pfizer’s Mylotarg, an anti-body drug conjugate once voluntarily withdrawn, returns to the market under a new dosing regimen for treating leukemia.

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

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

When it comes to getting the best out of quality by design, timing is everything.

EMA recognizes that a regulatory framework, under which medicines and diagnostics are developed and approved independently, may not be ideal.

Experts noted that the mechanism of drug release for these products after an overdose could put patients at risk.

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.

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.