Regulatory Oversight

Two of the medicines recommended for approval are orphan drugs.

The agency published guidance regarding OTC aspirin products that have cardiovascular-related images in their labels.

Data governance is necessary for compliance with current regulatory expectations for data integrity in pharmaceutical R&D and manufacturing organizations.

The level of formality in change control may be holding back your SOP progress, according to Siegfried Schmitt, principal consultant at PAREXEL.

Creating a quality culture can prevent the costs and challenges associated with receiving a consent decree.

A mutual recognition agreement to accept inspection data from eight EU regulatory authorities may reduce inspection burdens at global drug facilities.

The company has passed inspection by the UK Medicines and Healthcare products Regulatory Agency, and is now licensed to develop, manufacture, and pack non-potent and potent solid oral drug products at its site in Loughborough, England.

FDA sent a warning letter to Ridge Properties, LLC, after inspectors found a variety of current good manufacturing practice violations at the company’s Salem, OR facility.

EDQM held a symposium on microbiology to gather industry feedback on alternative testing methods for microbiological control and sterilization processes.

The European Commission and EMA have created an action plan to address challenges identified by stakeholders involved in developing advanced therapies.

The agency has published a continuity plan for its move from the United Kingdom.

The agency published guidance on developing antiviral drugs to treat respiratory syncytial virus infection.

Europe updates the guideline on excipients information in labeling and packaging.

The guidance gives recommendations for resolving scientific or regulatory issues with FDA regarding ANDA applications.

FDA published guidance on the format and content of REMS documents.

Both regulatory bodies are working on enhancements to their respective adverse event reporting systems in efforts to increase transparency and safety monitoring of drugs.

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

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.

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.

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.

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.