Amy Ritter, PhD

FDA issued a draft guidance, entitled ?Q11 Development and Manufacture of Drug Substances,? which is now available for comment according to a notice published on June 29, 2011, in the Federal Register. The draft guidance was developed in conjunction with the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), and describes approaches to developing process and drug substance understanding. It also provides guidance on what information should be provided in certain sections of the Common Technical Document (CTD).

Nanotechnology is science involving particles less than 100 nm in size. It is an emerging technology that is finding applications in medical products, food packaging, and cosmetics. Nanoscale materials can have different chemical, physical, or biological properties than their conventionally-scaled counterparts. As a first step in providing regulatory clarity about the use of such technology, FDA issued a draft guidance, titled "Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology" on June 9, 2011. The guidance lists points that FDA will consider when determining whether a product applies nanotechnology, and explains rationales for those points.

A South Carolina court found that Ortho-McNeill-Janssen Pharmaceuticals, a subsidiary of Johnson and Johnson (J&J), violated state consumer-protection laws by using misleading marketing for its antipsychotic drug, Risperdal. Janssen Pharmaceuticals, the maker of the drug, received a Warning Letter from FDA in April 2004 over misleading product claims made in a ?Dear Doctor? letter that the company sent to healthcare providers in November 2003. According to FDA, the Janssen promotional material minimized the risks of hyperglycemia-related adverse events associated with Risperdal, and misleadingly claimed that Risperdal was safer than other atypical antipsychotics.

Mylan, a generic-drug manufacturer, announced that it will be rebranding its Hyderabad, India-based subsidiary, Matrix Laboratories, as Mylan. In a company press release, Mylan Chairman and CEO Robert J. Coury states: ?This rebranding will lay the groundwork for continued expansion in India through our entry into the Indian commercial market with our own prescription pharmaceuticals within the next 12 months.? Matrix Laboratories is a supplier of active pharmaceutical ingredients (APIs), and a producer of APIs used to make generic antiretroviral therapies for the treatment of HIV/AIDS. Mylan acquired 51.5% of Matrix?s shares in 2007, and the remainder of its shares in 2009.

On May 12, 2011, a bill was introduced in the US House of Representatives to launch a national strategy for the development of regenerative medicines.

This month, FDA issued a new guidance for industry concerning the submission of summary bioequivalence data for abbreviated new drug applications (ANDAs). The guidance is meant to clarify the requirements for the submission of bioequivalence data that were published in 2009 (1). Federal regulations require that all bioequivalence studies performed for a given agent be submitted as part of the ANDA, regardless of whether the study confirms that the product is equivalent to the reference listed drug (RLD).

On Apr. 29, 2011, a federal appeals court has lifted a ban on federal funding for embryonic stem cell (ESC) research. The move was celebrated by researchers hoping to use such cells for research, but it is likely that the decision will be appealed. Embryonic stem cells are pluripotent cells derived from embryonic tissue in a process that usually results in the destruction of the embryo. The ban on funding did not apply to stem cells derived from adult tissue.

On Apr. 27, 2011, the National Institutes of Health (NIH) announced the composition of a working group tasked with making recommendations about the training of the next generation of biomedical researchers. The group will be co-chaired by Dr. Shirley Tilghman, president of Princeton University, and Dr. Sally Rocky, NIH deputy director for extramural research. Ten other scientists, most of them from academia, will complete the group.

The IMS institute has released its report on the use of medicines in the United States during 2010. The report looks at consumer spending on prescription drugs, and presents data on how many prescriptions have been filled, in which therapeutic areas, and compares use of generics with branded drugs.

A Record Number of Therapies for Cancer Currently in Development