Quality Systems

Based on its investigation into the safety of over-the-counter cough and cold drug products for children, the US Food and Drug Administration is recommending against such products for all children under two years of age.

Congressmen John Dingell and Bart Stupak have requested that the Government Accountability Office perform an updated assessment report in response to the US Food and Drug Administration?s potential development of a new class of behind-the-counter drugs.

The US Food and Drug Administration published a draft annex to its ICH Q8 Pharmaceutical Development guidance that clarifies that document?s key concepts.

Noven Pharmaceuticals received a warning letter from the US Food and Drug Administration stemming from an on-site inspection of the company?s manufacturing facility in Miami, Florida, concluded July 2007.

The US Food and Drug Administration?s website will no longer allow the public to electronically submit comments to its dockets.

The US Food and Drug Administration approved 69 new drug applications last year, the second lowest number of approvals in the past decade, according to the Jan. 15 edition of Drug Industry Daily.

The US Food and Drug Administration?s Subcommittee on Science and Technology released a report in November 2007 announcing that the agency is underfunded and cannot fulfill its mission. The FDA Science Board Advisory Committee has now discussed the report and decided to open a public comment period based on the subcommitee?s findings.

The US Food and Drug Administration released a draft plan for modifying its information technology infrastructure. The plan follows the renewal of the Prescription Drug User Fee Act (PDUFA IV).

Merck Sells Facility to Cherokee Pharmaceuticals, Inflazyme Announces Senior Management Resignations, More...

The $6.3 billion Indian pharmaceutical industry is at a crossroad. Aiming to be the international home for quality drugs, which could in itself propel India's market to $20 billion by 2015 according to recent estimates, the generic hothouse is clearly moving beyond its earlier low-cost mindset.

There is a need for current cleaning validation methods to be used for topical formulations. The authors highlight the issues and challenges encountered.

With 2007 projects wrapped up, or so we hope, forward-looking companies need to take their next step.

FDA’s May 1999 container-closure guidance has accelerated the requirements for extractable and leachable testing of container-closure packaging components. Since that date, additional recommendations have been made by industry groups to clarify how these issues should be addressed.

Fixing FDA lies in the hands of the government, but is the president-to-be paying attention?

Process efficiency is measured not only by what is kept, but also by what is thrown away.

As FDA implements new drug-safety policies, manufacturers will focus on quality and pricing.

QbD, PAT, design space, what's it all about? This seems to be a common industry response to FDA's directional push.

How much do you know about parallel trade? Perhaps you may have heard someone mention these words and have then switched off. In a sense, it's hardly surprising given the fact that most media coverage centres on interpretation of complex legal cases. By the time you reach the end of these types of articles, you can't work out what the mentioned companies were arguing about in the first place and on which technical details the case was judged. Yet, time after time, a legal ruling on a parallel trade issue rockets to the front pages of the pharmaceutical press and even, occasionally, the mainstream media.

Merck & Co. initiated a voluntary recall of 11 lots of its Haemophilus influenzae type B vaccine, Pedvaxhib, and two lots of its combination Haemophilus influenzae type B/ hepatitis B vaccine, Comvax.

Company and People Notes: West to reduce workforce, Eli Lilly's CEO and chairman to retire, more...

After a negative year in the news, China has finally agreed to improve the safety of its drug and food exports, according to the US Department of Health and Human Services.

The US Food and Drug Administration posted on its website a Warning Letter it sent to Wyeth Pharmaceuticals regarding a journal advertisement for the company?s ?Effexor XR? antidepressant.

The US Food and Drug Administration issued a rule that clarifies its requirements for current good manufacturing practices for aseptic processing, water standards, and verifications standards.

Tomorrow, Dec. 14, the US Food and Drug Administration?s Nonprescription Drugs Advisory Committee will discuss the safety and effectiveness of over-the-counter (OTC) cold medications containing phenylephrine.

The European Commission has approved Torisel (temsirolimus) for the first-line treatment of patients with advanced renal cell carcinoma (RCC), a condition that accounts for more than 80% of the estimated 85000 new cases of kidney cancer diagnosed in Europe every year.

Chi-wan Chen, deputy director of the Office of New Drug Quality Assessment (ONDQA) at the US Food and Drug Administration's Center for Drug Evaluation and Research, shares insight from FDA's pilot program that was designed to allow pharmaceutical companies to submit CMC information demonstrating application of quality by design.

Congress Focuses on FDA Inspections of Foreign Drug Facilities; Medical Students Oppose Big Pharma's Influence on Campus; FDA Revises Postmarketing Reporting Requirements

There are at least two major factors that will shape the manufacturing industry as a whole. Daniel Ruppar, Industry Manager (North America) for the Pharmaceuticals and Biotechnology Division of Frost & Sullivan predicts that, due to continued globalization, we can expect to see "growth centers for the industry move to emerging market sectors."

To keep up with applications, FDA promotes new testing and administrative methods.

How do you answer an inspector's questions? How do you validate analytical methods? One book has answers for compliance professionals.