Readers give advice on their best approach to handling (batch) rejection

Jim Miller's presentation at the 2008 AAPS Annual Meeting provides insight into outsourcing solutions.

Christmas is over. Everybody is back at work feeling a bit hungover, a lot poorer and alarmingly heavier...

Also, Crucell and DSM announce deals with GSK, Talecris, and CSL; Nobel Prize winner Luc Montagnier joins Viral Genetics; more...

The US Food and Drug Administration issued a draft guidance, Genotoxic and Carcinogenic Impurities in Drug Substances and Products: Recommended Approaches.

The US Food and Drug Administration dedicated historic Building One at the White Oak Federal Research Center in Silver Spring, Maryland.

A newly released study from the US Food and Drug Administration demonstrates that the printed information retail pharmacies provide to patients regarding medication use and risk of their prescriptions is not easy to read or understand.

The Pharmaceutical Research and Manufacturers of America (PhRMA) adopted measures to strengthen its Guiding Principles for Direct to Consumer (DTC) Advertisements about Prescription Medicines.

A US Food and Drug Administration guidance issued Tuesday provides new recommendations to applicants who wish to designate proposed products as orally disintegrating tablets (ODTs).

Also, BASF opens lab in Mumbai; Evotek president and CEO to resign; more...

The US Food and Drug Administration released a draft guidance document that contains questions and answers relating to new labeling requirements for over-the-counter drug (OTC) products that are marketed without an approved application under section 502(x) of the Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006.

President-elect Barack Obama officially nominated former Senator Tom Daschle as Secretary of Health and Human Services and named him the Director of a new White House Office on Health Care Reform late last week.

At its annual business briefing held last week, Merck & Co. outlined its short- and long-term strategy for growth. Its strategy is focused on increased penetration in emerging markets, the establishment of a business for developing follow-on biologics or biosimilars, and a new commercial model for product life-cycle management.

PharmTech's monthly newsletter, Equipment & Processing Report, reviews the Editor's Picks for the December 2008 edition from Spiroflow Systems and Sepha.

A surprising amount of the discovery and development life cycle is still based on manual and disconnected process steps.

Packaging a drug in a prefilled syringe may help extend a product's patent and distinguish it from competing products.

Also, NicOx and DSM make manufacture and supply pact for naproxcinod drug substance; NovaRx appointed Norrie Russell president and COO; more...

The US Food and Drug Administration has released Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics, which finalizes the draft from August 1999.

A Centers for Disease Control and Prevention (CDC) study confirmed that severe adverse reactions reported in the fall and winter of 2007 resulted from heparin contaminated with oversulfated chondroitin sulfate (OSCS).

The Environmental Protection Agency is proposing to add hazardous pharmaceutical wastes to the Universal Waste Rule to provide a system for disposing of hazardous pharmaceutical wastes.

The Synthetic Chemical Organic Manufacturers Association (SOCMA) has raised concerns over requirements for security vulnerability assessments (SVA) under the US Department of Homeland Security's (DHS) Chemical Facility Anti-Terrorism Act Standards (CFATS).

Industry experts are predicting that last week?s terror attacks in Mumbai, India may have at minimum some short-term effects on the pharmaceutical industry outsourcing business in that region.

The Federal Trade Commission (FTC) is seeking public comment on proposed revisions to its Guides Concerning the Use of Endorsements and Testimonials in Advertising.

FDA's Final Rule titled "Amendments to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals" takes effect Monday, Dec. 8, 2008.

Reps. John D. Dingell (D-MI), current chairman of the Committee on Energy and Commerce in the US House and Representatives, and Bart Stupak (D-MI), chairman of that committee?s Oversight and Investigations Subcommittee, said that moving the Food and Drug Administration Globalization Act and other measures for drug and food safety will be a key priority for the next Congress.

Also, AstraZeneca announces changes to its supply chain operations; Christian Velmer appointed head of Wyeth Canada; More...

The European Commission (EC) published a preliminary report stating that competition in the pharmaceutical industry does not work as well as it should.

A recent study shows life-science companies have difficulty in planning and executing change-management practices.