Regulatory Oversight

FDA's Brian Hasselbalch provides an overview of trends found in FDA quality inspections over the past year.

Keith Bader, senior director of technology at Hyde Engineering + Consulting discusses his presentation ?Establishing a design space: cleaning process development and validation,? which will be presented at Interphex 2013

Victor Hernandez of EMD Millipore discusses his upcoming session, "Current continuous process validation program: following FDA current guidelines,? which will be held at Interphex 2013

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

FDA's requirements for API manufacturers in regards to ICH Q7.

Industry experts discuss the effect FDA's 2011 process validation guidance has had on industry.

Brazil's major vaccine producer innovates with stem-cell research.

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.

Siegfried Schmitt, a principal consultant with PAREXEL, discusses how the EU's Falsified Medicines Directive will affect US API production.

Quality assurance of biological products is central to India's good distribution practices guidelines.

Prosecutors and regulators challenge manufacturing quality failings likely to cause patient harm.

A thorough investigation of all possible causes of deviations should be performed.

Adherence to GMP in API manufacturing is crucial in determining the safety of drug products.

FDA has released Guidance for Industry: Abuse-Deterrent Opioids?Evaluation and Labeling, Draft Guidance

Eli Lilly expects overall revenue growth in the coming year.

The health ministry of Brazil recently signed an agreement to obtain its production technology to locally develop the antiretroviral drug atazavanir sulfate.

The EU fine-tunes legislation for the Falsified Medicines Directive, which is due to take effect this month as part of efforts to better protect patients from counterfeits.

Siegfried Schmitt, a principal consultant with PAREXEL, discusses the EMA's guideline on process validation and how it compares with FDA's process validaton guidance.

Revalidation of cleanroom disinfection may be unnecessary, according to John S. Kent.

The management board of the European Medicines Agency (EMA) has endorsed the agency?s work programme and budget for 2013, which includes a budget of EUR231.6 million, a slight increase over 2012.

The agency recommends to avoid the use of to dibutyl phthalate and di(2-ethylhexyl) phthalate in CDER-regulated drug and biologic products, including prescription and nonprescription products.

Malvern Instruments Opens New Applications Laboratory in Brazil; Roche To Invest in Diagnostics Production in Germany; and More.

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.

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.

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).