This week the US Food and Drug Administration released the final version of Guidance for Industry: Providing Regulatory Submissions in Electronic Format-Drug Establishment Registration and Drug Listing.

In two whistleblower suits filed in May 2009, the United States and 16 states alleged that Wyeth (Madison, NJ) knowingly failed to offer the government the same discounts it gave to private purchasers of its drugs, as Medicaid laws require.

A book guides readers through the regulatory requirements for computerized quality systems.

Compliance features help patients follow medication regimens correctly.

Misleading the public about their investments-be it money or medicine-is unacceptable.

Follow-on biologics could unleash the potential of several industries and may even spark economic recovery.

Short-term problems in software or hardware lead to long-term manufacturing troubles.

Despite its shrinking domestic economy, Ireland is determined not to let its pharmaceutical industry fade into the shadow of global recession.

FDA leaders explain the purpose and plan for ICH's three quality guidelines.

Modern medicines have dramatically improved the health of millions of people worldwide, but the healthcare situation in industrialized countries is a stark contrast to that in the least developed countries where neglected diseases are still prevalent.

The United States Department of Health and Human Services (HHS) this week placed an initial order with Sanofi Pasteur (Lyon, France) for a vaccine to fight influenza A (H1N1) infection.

Archers Daniel Midland Company (Decatur, IL) is bringing on line a new propylene glycol plant in Decatur, Illinois, in the fourth quarter of 2009.

Novartis (Basel) signed an agreement that grants the company an exclusive option to acquire Elixir Pharmaceuticals (Cambridge, MA) upon the successful completion of a Phase IIa clinical study of Elixir's lead oral ghrelin antagonist, which is now the subject of preclinical studies.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) announced a pilot program, to launch in Sweden later this year, that will focus on coding and identification solutions.

The US Food and Drug Administration posted a draft guidance for industry, Presenting Risk Information in Prescription Drug and Medical Device Promotion, on its website May 26, that describes factors the agency considers when evaluating advertisements and promotional labeling for prescription drugs and medical devices.

Last week, the US District Court in Concord, New Hampshire, sentenced 63-year-old Robert McFadden, an attorney from Palm Springs, CA, to three years of incarceration to be followed by two years of supervised release for participating in the purchase and distribution of the HIV drug Serostim (somatropin recombinant), according to a US Department of Justice press release.

Also, Johnson & Johnson acquires Cougar Biotechnology; NIH launches program for rare and neglected diseases; PPD restructures leadership positions; more...

Pfizer's Pharmacia unit may be ordered to pay nearly $212 million as a result of a February 2009 Wisconsin court ruling that found the company guilty of violating the state's Medicaid fraud statute 1.44 million times.

The Senate confirmed late Monday night Dr. Margaret A. Hamburg, 53, to lead the US Food and Drug Administration.

Also, Oxford BioTherapeutics forms drug development pact with GSK; Avila Therapeutics names CEO; more...

The World Health Organization's Ad Hoc Policy Advisory Working Group on Influenza A (H1N1) Vaccines issued an update on May 18, 2009, on the production status of seasonal and A (H1NI) vaccines.

Last Monday, Billy Tauzin, president and CEO of the Pharmaceutical Research and Manufacturers of America (PhRMA), voiced the group's support for President Obama's efforts to reform the nation's healthcare system.

According to a report from Greystone Associates in Amherst, New Hampshire, prefilled syringes are replacing vials both in terms of injections and sector revenue, and as this trend continues during the next four years, the number of tailored injectable drug products reaching the market is set to escalate.

More than 70% of biotechnology executives fear that the European Commission's (EC) examination of anticompetitive behavior in the pharmaceutical industry, which began in January 2008, will weaken their patent protection, according to a new Marks & Clerk report.

The European Medicines Agency (EMEA) recently issued for public comment draft procedures on the evaluation of advanced therapy medicinal product (ATMPs).

The US Food and Drug Administration intends to automate and enhance the safety of the pharmaceutical supply chain by establishing electronic pedigrees (ePedigrees) for drug products.

Automation has been part of pharmaceutical processing for some time, but robotics have not yet found wide acceptance among drugmakers.

PharmTech's monthly newsletter, Equipment & Processing Report, reviews the Editor's Picks for the May 2009 edition from Continental Disc and Filimatic.