Regulatory Oversight

Prefilled-syringe line features automation and novel disinfection techniques.

Ruling has implications for intellectual property protection for innovator drugs in India.

Latin America's diverse growing market seeks regulatory harmonization.

The authors describe a method-validation-by-design (MVbD) approach to validate a method over a range of formulations using both design-of-experiment and quality-by-design principles to define a design space that allows for formulation changes without revalidation.

Novartis loses an appeal in seeking patent protection in India for its anticancer drug.

The Thai government is ramping up efforts to promote and develop the biotechnology sector in a bid to enhance its global competitiveness.

Strengthening government control or striving for compliance with international standards?

Draft guidance combines and supersedes previous guidance documents.

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.