Ingredients

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ePT--the Electronic Newsletter of Pharmaceutical Technology

Senator Sherrod Brown (D-Ohio), member of the Senate Health, Education and Labor Pensions (HELP) Committee, is requesting additional information from the US Food and Drug Administration and the pharmaceutical industry, concerning the regulation and practice of outsourcing.

ePT--the Electronic Newsletter of Pharmaceutical Technology

The European Chemicals Agency (ECHA), the European Union regulatory body overseeing the implementation of the REACH (Registration, Evaluation, and Restriction of Chemicals) regulation, began full operations on June 1.

ePT--the Electronic Newsletter of Pharmaceutical Technology

In an assessment report about medicinal products containing heparin, the European Medicines Agency (EMEA)'s Committee for Medicinal Products for Human Use (CHMP) said it could not draw firm conclusions about the level of risk associated with unfractionated heparins (UFH) contaminated with oversulfated chondroitin sulfate (OSCS). Nevertheless, CHMP recommended that contaminated lots be withdrawn completely.

ePT--the Electronic Newsletter of Pharmaceutical Technology

The US Senate approved a measure (HR 2642) that would provide the US Food and Drug Administration with $275 million in additional funding under a supplemental appropriations bill. The measure now goes before the House.

ePT--the Electronic Newsletter of Pharmaceutical Technology

The European Federation of Pharmaceutical Industries and Associations (EFPIA), the trade association representing European pharmaceutical manufacturers, issued recommendations to the public consultation launched in March by the European Commission's proposed drug anticounterfeiting measures. EFPIA's proposal includes a ban on drug repackaging.

PTSM: Pharmaceutical Technology Sourcing and Management

Increased investment by the pharmaceutical and biotechnology majors in offshore early drug development creates opportunities and challenges for outsourcing.

PTSM: Pharmaceutical Technology Sourcing and Management

Congress is considering proposing a new chemical policy similar to the European Union’s REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals) regulation. Batch and custom manufacturers weigh in on the debate.