Quality Systems

The US Food and Drug Administration posted the Prescription Drug User Fee Act (PDUFA) IV Drug Safety Five-Year Plan on its website.

The US Food and Drug and Administration and the International Serious Adverse Event Consortium (SAEC) released last week the first data on certain types of genetic-based adverse drug events.

After two years of hearings, more than 5000 pages of expert testimonies, and 939 medical articles, a special federal court ruled that there was little, if any, evidence to support the claim that substances in the measles, mumps, and rubella vaccine (including the use of thimerosal) had led to the autism of three children.

Congress and health policy groups have been pushing for and debating the merits of comparative effectiveness studies for years. Now, the freshly signed 2009 economic stimulus bill devotes $1.1 billion of the total $787 billion plan to this type of research.

The stimulus bill expands the healthcare safety net while boosting investment in health IT and comparative research.

To implement QbD and reduce business risks, teams should begin QbD collaboration early during process development.

The US Food and Drug Administration sent letters to manufacturers of certain opioid drug products, indicating that these drugs will be required to have a Risk Evaluation and Mitigation Strategy (REMS).

The US Food and Drug Administration withdrew this week its direct final rule on Reporting Information About Authorized Generic Drugs.

Taro Pharmaceuticals received a warning letter from the US Food and Drug Administration last week regarding its Brampton, Ontario, manufacturing facility.

The US Food and Drug Administration issued its first approval for a biological product produced by genetically engineered animals.

Congressman John D. Dingell (D-MI) introduced HR 759, known as the Food and Drug Globalization Act of 2009, which would amend the Food, Drug, and Cosmetic Act to address food, drug, and device safety, including registration of producers of drugs and applicable fees, documentation for admissibility of drug imports, country of origin labeling, and the inspection of producers of drugs and active pharmaceutical ingredients (API).

Also, PPD to acquire AbC.R.O.; Bilcare Global Clinical Supplies named Tony Moult general manager of Bilcare GCS Europe; more...

The United States Pharmacopeial (USP) Convention is pursuing greater collaboration with the US Department of Health and Human Services (HHS), and specifically, the US Food and Drug Administration.

GS1 UK, an independent organization that develops supply-chain standards, successfully completed the Pharma Traceability Pilot program and demonstrated the viability of a complete track-and-trace system for pharmaceutical products in a live, international supply-chain environment.

The US Pharmacopeial (USP) Convention has announced new standards for heparin and glycerin.

Former Senate Majority Leader Tom Daschle withdrew his name from consideration for US Secretary of Health and Human Services (HHS).

Without any GMP guidelines for excipients in Europe, change can't come soon enough for some industry groups.

GMP experts act fast to resolve some unusual and difficult problems.

The author defines sanitizers, disinfectants, and antibiotics, and examines the question of whether the rotation of disinfectants is scientifically warranted.

USP <231> Heavy Metals is transitioning toward the incorporation of modern quantitative technologies, but there is still much to be resolved.

To manage risk properly, industry must understand what it is and how to assess it

The Romanian pharmacetuical market has grown significantly in recent years, but with stagnation on the horizon, a path forward is needed.

Efforts to cut healthcare outlays will focus on drug costs, despite a drop in prescription sales.

FDA's role should not be overlooked as it has been in years past.

The American Society for Quality (ASQ), a membership organization that focuses on quality training in several industries including pharmaceuticals and healthcare, has adopted a new certification for good manufacturing practice (GMP) professionals.

Also, UCB will divest certain business in emerging markets to GSK; the KineMatik Group named Michael G. Jarjour president and CEO; more...

Senators Chuck Grassley (R-IA) and Herb Kohl (D-WI) have introduced S. 301, known as the Physician Payments Sunshine Act of 2009 to the 111th Congress.

Also, Elan explores strategic alternatives; NanoGuardian appoints John D. Glover to lead its Security Advisory Board; more...

Eli Lilly and Company has reached resolution regarding its previously reported government investigation into the company's US marketing and promotional practices for "Zyrexa" (olanzapine), an antipsychotic drug, thereby ending a government investigation started in 2004.

Last week, the US Food and Drug Administration issued a draft guidance for industry, Standards for Securing the Drug Supply Chain–Standardized Numerical Identification for Prescription Drug Packages, and launched a pilot program to help protect the pharmaceutical supply chain.