Regulatory Oversight and Compliance

FDA has issued a draft guidance to assist applicants in the submission of summary-level clinical-site data.

The European Medicines Agency has published a plan to help Europe?s regulatory network prevent, mitigate and manage shortages of important medicines following manufacturing problems.

To ensure the accuracy of scientific testing, protect the subjects to avoid data contamination.

White House and Congress likely to struggle over funding for bio/pharmaceutical regulation.

Domestic companies are changing their business models in response to recent drug price cuts.

FDA announced the availability of the guidance “Q11 Development and Manufacture of Drug Substances†in the Nov. 20, 2011 edition of the Federal Register.

Manufacturing and in-depth characterization provide basis for demonstrating product equivalence.

Even when all is well at the facility, one must expect the worst while braving the elements.

The European Medicines Agency has added granularity to its biosimilars approval pathway by releasing a guideline on biosimilar monoclonal antibodies (mAbs).

The government of Turkey is drawing up a program in coordination with the pharmaceutical industry to create ways to make the country a regional production center for pharmaceuticals serving Europe, Central Asia, and the Middle East.

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) has finalized a risk-based inspection planning tool for inspectorates to use in applying science- and risk-based principles to planning GMP inspections.

New England Compounding Center gets 483 after linked fungal meningitis outbreak.

IQ Consortium representatives explore and define common industry approaches and practices for applying GMPs in early development.

Foreign firms struggle against stricter patent laws, but all is not lost.

Only the strong survive when it comes to pharmaceutical packaging and shipping.

The promise of the Generic Drug User Fee Amendments of 2012 is to end multiyear reviews of new generic drugs and the ever-growing queue of pending applications.

EMA has been increasing its interactions with other regulatory agencies across the globe. The agency's most talked about collaboration is with FDA, but EMA has also been intently focused on bolstering its relationship with its counterparts in Japan, India and Russia.

The European Medicines Agency has abolished its Cell-based Product Working Party and Gene Therapy Working Party, with the aim of improving efficiencies and optimizing the use of available expertise.

ISPE has published a new guidance titled ISPE Good Practice Guide: Quality Laboratory Facilities, which defines design guidelines for quality laboratories.

The European Generic Medicines Association (EGA) has raised concerns about the potential fees to be charged by the European Medicines Agency for pharmacovigilance activities

The European Medicines Agency has launched a public consultation concerning its inventory of pediatric medicines with the aim of highlighting where further R&D efforts are required. The consultation is the first of its kind in this area.

IQ Consortium representatives explore and define common industry approaches and practices for applying GMPs in early development, with a focus on stability.

International trade can be great for business, but breaking border laws can put one in hot water.

Import controls and risk strategies aim to promote quality and spur new drug development.

Brazil takes first steps towards gaining quality requirements for pharmaceutical excipients.

The Johnson & Johnson subsidiary Janssen Pharmaceuticals has announced a settlement and consent decree with 36 states and the District of Columbia in regards to previously disclosed allegations related to the company's marketing and promotional practices relating to Risperdal (risperidone).

Regulatory Roundup: ISPE issues ozone sanitization guidance and EMA amends incident management plan

After a series of government reforms that are appealing to both domestic and foreign players, the Japanese pharmaceutical market is making a comeback.

Import controls and risk strategies aim to promote quality and spur new drug development.

The authors compare direct combustion with rinse and swab sampling methods.