Quality Systems

The Senate Appropriations Committee approved a measure last week that would restrict the use of certain patent settlements by innovator-drug companies under which innovator-drug companies pay generic-drug companies to delay the entry of a generic product in so-called "pay-for-delay" cases.

Industry's focus on cost cutting has led to a dangerous gap in training and knowledge.

The authors discuss the statistical tools used in experimental planning and stategy and how to evaluate the resulting design space and its graphical representation.

Cases of overlooking proper packaging, reconstitution, directions, and dissolution.

FDA chemistry reviewers in the Office of Generic Drugs provide an overview of common deficiences cited throughout the Chemistry, Manufacturing, and Controls section of ANDAs.

Manufacturers and regulators on both sides of the ocean move to ensure the safety of heparin and other globally distributed drug products.

Industry can meet its responsibility to society by considering innovative pricing and partnerships.

Three therapies under review could help Americans attain a healthy weight.

Before embarking on an outsourcing relationship, it's important to be aware of FDA's expectations.

The different pathways to regulatory approval of a biosimilar vary worldwide, ranging from no pathways at all in some developing countries, to the complex and precise mechanism that exists in Europe.

A new guideline for conducting bioequivalence studies was adopted by the CPMP in January and it becomes fully effective as of August 2010.

We speak to The European generic Medicines Association about the environment for biosimilars.

The recent amendment to Annex 1 has seen controversial changes relating to the capping of vials.

New isolator and disposable technologies are set to assume a greater role in pharma manufacturing, according to a recent conference in Germany.

As biopharmaceuticals will soon make up 50% of new drug approvals there has been a significant rise in interest in the field of biosimilars.

The biggest differences between the development of a biosimilar and a generic medicine lie primarily in the preclinical and clinical stages.

Why the primary defence against biosimilars is to develop better molecules that can be launched quickly.

French pharma giant Les Laboratoires Servier SA has been accused of providing "misleading" and "incorrect" information during the EC's antitrust investigation.

In 2009, the European Commission (EC) Customs Union seized 11,462,533 medicines and medical products for suspected violations of intellectual property (IP), according to the Commission's annual report on EU Customs Enforcement of Intellectual Property Rights, which was published last week.

European Medicines Agency Issues Drug Review Update; And More

The US Food and Drug Administration has joined the Tox21 collaboration, which aims to develop ways to more effectively predict how chemicals will affect the body and environment.

The pharmaceutical industry?s increasing interest in inhaled drugs has prompted several researchers to propose standard dissolution-testing methods for these products.

The Council of Europe (CoE) is hoping its 'Medicrime' treaty can help curb the lucrative global trade in fake medicines.

States can reduce their Medicaid programs' healthcare expenditures by changing laws to enable generic drugs to be substituted for branded medications more easily and quickly, according to a new study conducted by CVS Caremark, a large pharmacy healthcare provider.

The Laboratory Services Division of the Philippine Food and Drug Administration (FDA) has attained internationally recognized accreditation for its testing and calibration laboratories, according to a July 12, US Pharmacopeia (USP) announcement.

The Council of Europe (CoE) is hoping its Medicrime treaty can help curb the lucrative global trade in fake medicines.

The Pharmaceutical Research and Manufacturers of America (PhRMA) announced earlier this week that John J. Castellani will replace Billy Tauzin as President and Chief Executive Officer.

Crunch time is rapidly approaching in Roquette?s long-running patent dispute with SPI Pharma, with the case scheduled to go to trial on 4th October 2010.

Changes to Part 2 of the EU GMP guide will come into force by 31 July 2010 in order to bring it in line with the ICH Q9 guideline on Quality Risk Management. As a result, it will no longer be identical to the ICH Q7 guideline on APIs - a harmonised guideline for the US, Europe and Japan.