Quality Systems

To address the increasing popularity of drug-injector systems, the US Food and Drug Administration last week released a Draft Guidance for Industry titled, Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products.

The US Food and Drug Administration released a new guidance for industry, Medication Guides-Adding a Toll-Free Number for Reporting Adverse Events, on June 8, 2009.

The chief operating officer (COO) of Mylan (Canonsburg, PA), one of the world's leading generic drug manufacturers, has condemned the launch of authorized generic drugs during 180-day exclusivity periods.

The European Commission's (EC) Directorate-General for Enterprise and Industry (EC-DG Enterprise) announced last week that it will not continue preparing a commission directive on good manufacturing practices (GMPs) for certain excipients.

The United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) is seeking opinions on a European Commission (EC) proposal that would allow drugmakers to disseminate certain information on prescription medicines directly to European Union patients.

Members of the House Committee on Energy and Commerce, Chair Emeritus John D. Dingell (D-MI), Chair Henry A. Waxman (D-CA), and Reps. Frank Pallone (D-NJ), Bart Stupak (D-MI), Diana DeGette (D-CO) and Betty Sutton (D-OH) released last week a discussion draft of the Food Safety Enhancement Act of 2009.

The International Serious Adverse Event Consortium (SAEC), a nonprofit partnership, has helped the US Food and Drug Administration gain significant understanding of the genetic basis for drug-induced liver injury, according a new FDA press release.

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.

A successful quarantine program requires collaboration among all departments of a pharmaceutical facility.

As regulators work to curb counterfeiting, industry finds benefits to gaining granular data about the supply chain. This article contains bonus online-exclusive material.

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.

Agency officials and manufacturers anticipate stricter enforcement of drug safety and quality.

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

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.

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.

The US Pharmacopeia will release for public comment a new USP <231> Heavy Metals general chapter. Is your laboratory ready to handle the changes? Find out at Pharmaceutical Technology's June 4 webinar. And check out our interactive metals and limits table.

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

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.

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 first project report on FDA's Sentinel website, discusses the evaluation of existing methods for safety signal identification.

Also, Takeda to consolidate operations in Ireland; FDA to redesign website; Archemix names president and CEO; more...

The US Food and Drug Administration issued a draft guidance for industry, Label Comprehension Studies for Nonprescription Drug Products, in the May 1 Federal Register.

This week, pharmaceutical industry regulators and manufacturers moved quickly to address public health concerns regarding the outbreak and spread of H1N1 virus infection (swine flu). The following is an overview of key developments.

A recent poll shows the public's view of the US Food and Drug Administration has improved somewhat, but better oversight of drug safety is still needed.