News

The US Food and Drug Administration may soon ask doctors to undergo special training to be able to prescribe powerful narcotics, Dr. Bob Rappaport told The New York Times last week. Rappaport, director of FDA's Anesthesia, Analgesia and Rheumatology Products division, said the agency is considering recommending additional education for doctors in early 2009.

The concept of the the triple bottom line incorporates a company's financial, social, and environmental performance. As a result, an increasing number of companies are investigating how sustainable, green technologies and practices can help them stay competitive in a challenging regulated market.

Decontaminating pharmaceutical manufacturing facilities is essential for producing safe and pure drugs. The most commonly used decontaminant in the industry has been sublimated formaldehyde.

PharmTech's monthly newsletter, Equipment & Processing Report, reviews the Editor's Picks for the August 2008 edition from OYSTAR Manesty and Hawk.

The US Food and Drug Administration issued a new draft guidance for public comment on sterile manufacturing.

Actavis Totowa LLC, the US subsidiary of the generic drug manufacturer Actavis Group, is announcing a voluntary recall to the retail level of all drug products manufactured at its Little Falls, New Jersey, facility. This is a precautionary, voluntary action by Actavis following an inspection conducted by the Food and Drug Administration earlier this year.

The US Food and Drug Administration has distributed a draft of Guidance for Industry: Residual Solvents in Drug Products Marketed in the United States for public comment.

The US Food and Drug Administration seeks contractors that will identify, describe, and evaluate potential data sources or data environments that could participate in the agency's Sentinel Initiative.

Also, Ortho Biotech recalls one lot of "Procrit" due to cracked vials, more appointments at Actavis, more...

The House Committee on Energy and Commerce issued a revised discussion draft to the Food and Drug Administration Globalization Act of 2008.

Next week, the US Food and Drug Administration's communications with pharmaceutical companies will change, and the agency will begin issuing complete response letters in place of approvable letters.

Bristol-Myers Squibb is seeking to acquire the biopharmaceutical company ImClone Systems (New York) for $4.5 billion or $60 per share. BMS currently holds a 17% stake in ImClone.

The US Food and Drug Administration released its user fee rates for fiscal year 2009 last Friday.

Also, Bilcare Global Clinical Supplies opens new headquarters in San Francisco, Sigurdur Oli Olafsson named CEO of Actavis Group, more...

The pharmaceutical industry?s outsourcing practices receive increased attention as Congress evaluates the role of outsourcing in drug-safety issues.

Strong profitability and good growth prospects bode well for the global market for contract research organizations.

Patent pressures, changing disease profiles, and higher costs force companies to fight for the top.

Agents report unusual chemistry, abnormal data analysis, and unconventional work practices.

Myth versus Reality: What does Q10 implementation really mean for my company?

Surrounded by competition, Vietnam's 2020 vision focuses on building a biotech sector worthy of its Asian neighbors-as well as the growing global biopharmaceutical market

Legislative decisions to increase Medicare's formulary may lead to a fight over drug approvals.

USP's guideline for pending monographs can speed up publication of monograhs and time to market.

Despite its flaws, a recent release fills a need for books about pharmaceutical project management.

Extractables and leachables are a growing concern for pharmaceutical manufacturers and regulatory bodies.

The European Medicines Agency recommended strengthening the warnings for oral moxifloxacin medicines and concluded that these drugs should only be prescribed to treat acute bacterial sinusitis, acute exacerbation of chronic bronchitis, and community-acquired pneumonia when other antibiotics cannot be used or have failed.

Also, Cobra Biomanufacturing to extend collaboration and form joint venture with ViroMed, Epix Pharmaceuticals CEO resigns, more...

Pharmaceutical companies developing new drug candidates for Hepatitis C virus infection now can test their compounds with a novel culture system that mimics the biology of HCV infection in humans.

As part of a new strategic direction, GlaxoSmithKline CEO Andrew Witty outlined three priorities that are designed to improve the company's long-term financial performance.

Senator Sherrod Brown sent a letter to Richard T. Clark, president and chief executive officer of Merck (Whitehouse Station, NJ), to ask for information about the company's reliance on global outsourcing for the manufacture of pharmaceutical ingredients and finished products.

The US Food and Drug Administration seeks applicants for its new Commissioner’s Fellowship Program for scientists, engineers, and health professionals. The two-year program will help prepare the agency to replace a large number of FDA staff who are preparing to retire as well as meet future goals.