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The News in Depth

Genzyme Consent Decree Results in $175 Million Fine, Drug Shortages Will Continue

Genzyme’s consent decree for GMP violations at its Allston, Massachucetts plant will require it to pay a $175 million “disgorgement fee” and bring the plant back into compliance with applicable regulations within a specified time frame, during which time shortages of several of its drugs will continue. The consent decree was filed in the U.S. District Court for the District of Massachusetts on May 24, 2010, and is subject to court approval....

European Trade Associations Step Up to the Plate on Drug Counterfeiting

Two trade associations in Europe, through separate but related efforts, are advancing the dialogue on preventing counterfeit medicines from entering the legitimate drug supply chain: one by publishing a set of guiding principles to call attention to the issue; the other by successfully executing a pilot program on security of drug products in the supply chain....

Protecting the Public Health Trumps Explicit Legislative Mandate, FDA’s Chief Counsel Tells FDLI

FDA’s mandate to protect the public health requires making decisions in situations where there is no law explicitly empowering it to act, FDA Chief Counsel Ralph Tyler stressed at the Food and Drug Law Institute (FDLI) Annual Meeting in late April. In turn, Tyler explained that a key role for FDA lawyers is to be advocates for the agency in helping it reach its policy and enforcement goals in situations where waiting for approval from Congress does not allow a timely enough decision....

FDA to Partner with State Agencies on Recalls and Regulatory Actions

FDA is developing national procedures for engaging state agencies in the follow-up to recalls and moving toward partnerships with state agencies to allow the use of state data to support other regulatory actions....

EMA Updates Facility Inspection Procedures to Align with EU GMP Guide Revisions

The European Medicines Agency (EMA) has updated its GMP facility inspection procedures to align with recent revisions to its EU GMP Guide reflective of ICH Q8-10 principles....

Nanotechnology Under the Microscope at FDA

The rapidly expanding use of nanotechnology in therapeutic formulations is driving FDA to better define the regulatory and analytical framework needed to assess and address the potential concerns involved....

Particulates in Biotech Products: Standard Setting Effort Gaining Traction

Visible and sub-visible particles in parenteral products and the need for developing measurement standards is drawing attention from regulators and industry at biotech conferences....

Process Modeling in Focus for EU and US Reviewers

The understanding of the potential uses and value of models in facilitating manufacturers’ development efforts and helping regulators understand their complex processes is growing....

FDA Views Clinical Linkages as Key QbD Implementation Gap

As quality-by-design (QbD) implementation progresses, FDA is becoming aware of the scientific gaps that still need to be filled in. One area in particular that has generated considerable attention among industry and regulators is “understanding the link between what that product is and how it works in the patient – that is, integrating the field of biopharmaceutics into QbD,” ONDQA Acting Deputy Director Christine Moore stressed at a recent conference.

FDA Touting Benefits of Continuous Manufacturing

One area, in particular, that FDA is focusing on as a significant opportunity for advancing its quality-by-design objectives is continuous manufacturing. CDER officials’ have been highlighting their interest in continuous manufacturing at recent conferences, noting the recent progress that has been made in converting the concept into practice....
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