Regulatory Oversight and Compliance

Compounding, tracking legislation moves forward

Falsified Medicines Directive requires imported APIs to have written confirmation of GMP standards.

European governments are under pressure to take regulatory action, but solving the problem of medicine shortages is not as straightforward as it seems.

Increased manufacturer outsourcing requires clear policies and written agreements with CMOs.

The EMA's Committee for Medicinal Products for Human Use has recommended granting of marketing authorizations for the first two monoclonal antibody biosimilars.

Cocrystals can enable the formulation of solid dosage drugs, but the FDA's final guidelines have left concerns about how their use could impact development timelines, the drug product manufacturing process, and the intellectual property position of products containing cocrystals.

EMA's revised guideline on biosimilars containing biotechnology-derived proteins is published for public consultation.

FDA cites cGMP violations of finished pharmaceuticals at the company's facilities in Marion North Carolina and Jayuya, Puerto Rico.

Bills to regulate drug compounding and establish a national track and trace system face political and policy differences.

A science- and risk-based approach to verify and demonstrate that a process operating within predefined specified parameters consistently produces material that meets all its critical quality attributes.

Companies can use metrics as a tool to help drive positive change and quality process improvements.

An overview of the latest regulatory developments for malaria drugs, biosimilars, and global standards.

Company receives notice from FDA for not fully investigating foreign particles in APIs and finished products made from its facility in Ingelheim am Rhein, Germany.

The draft guidance describes how quality agreements can be used to delineate the responsibilities of contract manufacturers involved in the cGMP manufacture of APIs and finished drug products.

FDA has released guidance on best practices for conducting and reporting pharmacoepidemiologic safety studies.

EMA streamlines orphan drug application procedure.

Manufacturers work with international authorities to harmonize drug registration and supply-chain oversight.

While there are those who want combination products to be controlled by a centralized pharmaceutical-type approval system, the majority of the medical technology industry wants to retain a decentralized device-focused approach.

FDA faces budget crunch; Supreme Court hears key cases

The author provides a review of FDA's guidance document, Guidance for Industry: Q11 Development and Manufacture of Drug Substances, and its relation to the International Conference on Harmonization's Q11 document and its application to the industry.

FDA issues draft guidance to minimize medication errors.

FDA has released Guidance for Industry: Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination.

Draft guidance combines and supersedes previous guidance documents.

Opioid abuse generates calls for efforts to curb distribution, develop abuse-resistant formulations.

The European Union authorities are stepping up their efforts to incorporate quality-by-design principles into their regulations and guidelines.

The 2013 Excipient Information Package (EIP) User Guide is now available for free download from the International Pharmaceutical Excipients Council (IPEC)-Americas.

Discussions are underway as the pharmaceutical sector calls for greater consistency in the global monitoring of GMP compliance and quality testing of APIs and finished medicines.

Vaccine development is benefiting from manufacturing advances and support for global health.

The European Medicines Agency?s Committee for Orphan Medicinal Products (COMP) is seeking to expand its international cooperation in 2013.

FDA has released a list of more than 50 guidance documents planned for 2013.