Quality Systems

The US Food and Drug Administration issued a draft guidance for industry on the Submission of Summary Bioequivalence Data for Abbreviated New Drug Applications (ANDAs).

Also: Sanofi-aventis acquires BiPar Sciences; FDA issues Warning Letter to Chinese heparin manufacturer; Halo Pharmaceutical appoints chief scientific officer; more...

On April 2, the Health Products and Food Branch of Health Canada and EU (consisting of the European Commission [EC] and European Medicines Agency [EMEA]) released "Implementation Plan for Regulatory Cooperation on Medicinal Products."

The United States Pharmacopeial (USP) Convention signed a memorandum of understanding (MOU) with the Federal Service on Surveillance in Healthcare and Social Development of the Russian Federation (Roszdravnadzor) last week in Moscow.

In late March, the US Food and Drug Administration sent warning letters to nine companies to stop manufacturing 14 unapproved narcotic drugs. Less than two weeks later, on Apr. 9, the agency amended those letters when it realized that one particular unapproved opioid (a high concentrate of morphine sulfate oral solution) is desperately needed by patients.

ATSM and ICH approaches, in place of traditional qualification or integrated commissioning and qualification (C&Q) using impact assessment, can make projects and processes more efficient and help facility owners and designers ensure compliance, quality, and safety when defining acceptance criteria for their critical process systems and equipment.

The US Food and Drug Administration issued 14 untitled letters last week to pharmaceutical companies in violation of the Federal, Food, Drug, and Cosmetic Act for publishing misleading and misbranded information about their drug products online.

Although industry is tightening its belt, contract manufacturers across Europe are actually making out quite well by taking on additional projects and new roles.

Senator Charles Grassley (R-IA) sent a letter to Frank Torti, acting commissioner of the US Food and Drug Administration, to express concern about a memo that Torti sent to agency staff.

Also, SOCMA changes name; two FDA approvals; Biogen Idec names chief operating officer; more...

The United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) seized nearly half a million pounds worth of counterfeit medicines on Mar. 26, 2009 in Middlesbrough, England, according to a MHRA press release.

Brief pharmaceutical news items for April 2009.

FDA is poised to gain authority and resources to ensure the quality of food and drugs.

Standards data is helpful, but FDA needs to apply its information across the board. This article contains bonus online-exclusive material.

Obama's cost-containment and science-innovation initiatives need to overlap.

President Obama's economic recovery plain includes goals such as reducing the number of uninsured citizens and improving the quality of healthcare.

The financial and economic downturn is likey to have long-term implications for outsourcing.

GMP agents report on old products, aseptic violations, and unexpected emotions.

Operational excellence awaits, but only if you can implement PAT successfully.

Steps companies can take to help safeguard patients and the pharma supply chain.

Bernard Siegel, Founder and Executive Director of the Genetics Policy Institute (GPI), explains why lifting stem cell funding restrictions by executive order is only the first step towards safeguarding stem cell research.

President Obama's plan for increasing drug comparative effectiveness research is moving forward. The 15 members of the Federal Coordinating Council for Comparative Effectiveness Research, created to manage the $1.1 billion allocation designated for the research in Obama's American Recovery and Reinvestment Act of 2009, were named last week, according to a Mar. 19 press release from the US Department of Health and Human Services

Also, Hospira to reduce workforce; WuXi AppTech makes senior appointments; more...

In a case decided on Mar. 20, 2009, the US Court of Appeals for the Federal Circuit invalidated a US Patent and Trademark Office (PTO) Final Rule that governed the number of applications that parties may file to seek continued examinations of patent applications.

A bipartisan bill that would establish a regulatory pathway for the approval of biosimilars was introduced into the US House of Representatives last week.

Instead of protecting the public from unsafe drugs and contaminated foods, the Food and Drug Administration is a "hazard to public health," stated President Barack Obama in announcing his choices to head the agency and new efforts to improve food safety. Margaret Hamburg will be FDA's new commissioner, and Joshua Sharfstein principal deputy commissioner for drugs and medical products.

The US Pharmacopeial Convention (USP) and the National Institute for the Control of Pharmaceutical Biological Products (NICPBP), China's agency for overseeing the quality of large- and small-molecule drugs, signed a memorandum of understanding (MOU) to bolster the quality of medicines in China and in the countries that buy Chinese drug products, including the United States.

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.