Quality Systems

Ending a long, closely watched debate over the issue of federal preemption, the US Supreme Court on March 4, to uphold a $6.8 million Vermont Supreme Court decision of Diana Levine against Wyeth Pharmaceuticals (Madison, NJ).

The Synthetic Organic Chemical Manufacturers Association (SOCMA) said last week that Congress is likely to the include inherently safe technology (IST) measures in proposed chemical site-security legislation that is likely to be introduced in late winter or early spring.

Senators Byron Dorgan (D-ND), Olympia Snow (R-ME), John McCain (R-AZ), and Debbit Stabenow (D-MI) introduced a bill March 4 that would allow pharmacists and wholesalers to import prescription drugs from Australia, New Zealand, Japan, Switzerland and the European Union.

President Obama's Fiscal Year 2010 (FY 2010) budget includes support for a regulatory pathway for follow-on biologics.

On March 3, the US Food and Drug Administration released a draft guidance for Industry entitled "Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products: Content and Format."

In a press release dated Feb. 25, 2009, the US Food and Drug Administration charged that Ranbaxy Laboratories's (Gurgaon, Haryana, India) Paonta Sahib facility falsified data and test results in approved and pending drug applications.

FDA issued a notice in the Federal Register last week requesting comments on the automated collection of four additional pieces of information that are not available in the US Customs and Border Protection's (CBP) data set.

Broader disclosure of drug prices and conflicts of interest are central healthcare reform issues.

Industry has changed, but its basic tenets have not. INTERPHEX's RJ Palermo discusses a 7-step process to keep pharma moving forward.

The source of a problem reveals itself after some investigation, or it may crash down on you.

The author tests the ruggedness of VRL viewing conditions and defines optimal viewing conditions.

An updated book provides essential information for scientists who monitor microbial quality.

With the economy down and multinational firms capitalizing on patents in developing countries, India's R&D sector still has a long way to grow.

When applied as part of a structured approach, predictive modelling can provide deep process and product understanding, and can enable true, continuous process validation as envisioned by ICH guidelines.

PAT guidance has been available from FDA for more than 4 years, but there have been no apparent breakthroughs in large-scale upstream production. Will companies consider using on?line chromatography to change this?

The US Food and Drug Administration stated its considerations in regards to the three draft annexes to the International Conference on Harmonization's Q4B document.

The US Food and Drug Administration has released a draft guidance for industry entitled Influenza: Developing Drugs for Treatment and/or Prophylaxis.

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.