Manufacturing

In an effort to clarify its policy on the use and creation of genetically engineered animals (GE animals), the US Food and Drug Administration released the draft guidance "The Regulation of Genetically Engineered Animals Containing Heritable rDNA Constructs" on September 18.

The US Food and Drug Administration has issued two warning letters to Ranbaxy Laboratories.

Also, Quintiles to expand Singapore operations; Christine A. Poon, chairman of Johnson & Johnson's pharmaceuticals group, to retire; more...

Earlier this month, the US Food and Drug Administration announced that it will be posting quarterly reports on its website regarding potential drug safety issues.

MannKind and Pfizer (New York) agreed that the former company will help patients who need inhaled insulin switch from Pfizer's "Exubera" medicine to MannKind's "Technosphere Insulin" drug.

The US Food and Drug Administration launched a new website to educate the general public about direct-to-consumer (DTC) advertising of prescription medications.

The US Food and Drug Administration has updated its draft bioequivalence recommendations for several products, and added 66 new draft product-specific guidelines since October 2007.

FDA has issued a Final Rule titled "Amendments to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals."

Also, Human Genome Sciences enters pact with Hospira, Zosano Pharma names Gail Schulze chair and CEO, more...

Companies launched 25 new active substances in 2007, a decline of 19% from the previous year, according to a new report from Parexel International.

Also, Novartis stops development on "Aurograb," Zealand Pharma appoints David H. Solomon as CEO, more...

CMC service providers are doing well, but clinical and preclinical CROs are doing even better.

The US Food and Drug Administration will hold a public meeting this month to gain public input on implementing the recommendations of the Nanotechnology Task Force report, taking another step closer to setting a regulatory framework for nanotechnology for pharmaceuticals and medical devices.

The pharmaceutical majors deploy green-chemistry strategies to improve the synthesis of active pharmaceutical ingredients and intermediates.

A recent book shows the links between synthesis, catalysis, and environmental protection.

Sterile manufacturing may be the next aspect of pharmaceutical manufacturing to consider in the continuous process paradigm.

Equipment qualification is a critical step in ensuring that a product or service is provided accurately and consistently with regards to manufacturing and testing. The time-saving attribute of adding prerequisites to a qualification program, along with the benefit of gaining the ability to track and trend problem areas, make the addition both worthwhile and cost-effective.

The selection of the chiral stationary phase is an important consideration in separating enantiomers when using high-performance liquid chromatography, supercritical fluid chromatography, and simulated moving bed chromatography.

Brief pharmaceutical news items for September 2008.

This year, the employment survey will acknowledge the industry's best employers.

Identifying the most sustainable packaging for a product is rarely a simple exercise.

FDA is taking several measures to ensure that imported drugs meet manufacturing standards.

Criticality management combines pharmaceutical product, process, and material knowledge and risk management in one approach, which is reflected in a single document.

With economics and politics in the way, can we defeat the malaria epidemic before it defeats us?

This tutorial paper is meant to aid in dielectric-sensor selection