Regulatory Oversight

The agency published guidance on data integrity as it is relates to CGMP compliance.

The agency published draft guidance on prescription requirements, hospital pharmacies, and outsourcing facilities for compounders.

The agencies detail the results of their three-year collaboration.

The agency issues safety guidance to minimize medication errors relating to product design and container closure design.

The FDA guidance describes information to provide to the agency when submitting a proposed proprietary name.

The agency released a draft reflection paper on the extrapolation of data from adults to children in the development of pediatric drugs.

A global API marketplace increases the burden of supply chain monitoring for drug companies.

The authors discuss the concept design of a versatile, sustainable, small-scale facility in Malta that conforms to the European Union’s current good manufacturing practices.

The European Commission publishes regulations on mandatory packaging safety features to fight counterfeiting.

The European Medicines Agency report provides an analysis of the health-technology assessment pilot program, which began in 2010 and completed in March 2016.

The draft guidance states information concerning a clinical study of a biosimilar should only be included if it is necessary to demonstrate the safety and efficacy of the drug.

Pharma has huge responsibilities resting on its shoulders to deliver safe and effective medicine.

The report examines the increased number of companies cited by regulators for data integrity issues.

The draft guidance outlines ways applicants can test for abuse deterrence in solid oral opioid drugs.

Revised versions of ISO 14644 adopt changes to sampling procedures and monitoring plans for cleanrooms.

The agency strengthens its support for treatments of unmet medical needs with launch of new PRIME scheme.

Siegfried Schmitt, principal consultant, PAREXEL, discusses how the regulatory requirements for CGMPs is the different phases of drug development and manufacture.

Data integrity is a widespread, global problem that must be addressed.

The EU is striving to reduce the costs and administrative burden facing pharmaceutical manufacturers when complying with variations regulations for keeping authorization dossiers up to date.

Data integrity has become a more serious compliance problem at pharmaceutical manufacturing plants throughout the world.

The agency has revised its good pharmacovigilance practices guide on risk management systems.

Regular removal of residues from disinfectants and sporicidals is important for improved aesthetics and safety in cleanrooms.

The agency published guidance on immunogenicity-related considerations for low molecular weight heparin.

UK pharmaceutical companies face £45 million in fines after entering pay-for-delay agreements for generic versions of paroxetine.

Multiple data-integrity violations results in FDA warning letter for Mumbai, India-based Ipca Laboratories.

The agency prepares a plan to implement new packaging safety features.

The author reviews FDA's final Animal Rule guidance.

Susan Schniepp, distinguished fellow, and Andrew Harrison, chief regulatory affairs officer and general counsel, both of Regulatory Compliance Associates, discuss how to create a robust CAPA system and how to identify root cause.

Choosing the right excipient manufacturer can help ensure the use of quality excipients.

Steven Denham, director of biostatistics at MPI Research, discusses the impact the Standard for Exchange of Nonclinical Data may have on the pharmaceutical industry.