Last week, the US Pharmacopeia published proposed standards for the content, language, format, and appearance of prescription drug labels in an effort to enhance patient understanding and safety.

With dozens of prescription drugs soon to lose patent protection and few likely blockbusters in industry pipelines, drug developers are "aggressively" changing the way they do R&D, according to the Tufts Center for the Study of Drug Development (CSDD).

As part of its transparency initiative, which began in June 2009, FDA launched a website during the first week of January 2011 that addresses basic questions for industry about regulated products.

FDA Publishes CDER Presentation, and more.

Direct-to-consumer (DTC) advertising is firmly entrenched in the US, but has historically been considered as an inappropriate means of communication in Europe for prescription-only medicines.

The threat of counterfeit medicines in the next year will be more severe than ever, according to a survey of 1000 companies conducted in October 2010 by Pharma IQ.

GlaxoSmithKline (GSK) issued a statement on Jan. 2, 2011, to respond to a 60 Minutes segment that aired on Jan. 2 that focused on quality-control problems at a former GSK manufacturing facility in Cidra, Puerto Rico.

Gilead Sciences to Acquire Arresto Biosciences; Sartorius Appoints Head of Lab Business; and More.

John Taylor to Serve as Acting Principal Deputy Commissioner after Joshua Sharfstein's Departure, and more.

FDA received the authority to mandate recalls of food under a new food-safety bill. Efforts are underway in the House to grant the agency this power for pharmaceuticals as well.

An assessment of the progress and needed activity to achieve global sustainability goals shows Brazil and India leading G20 economies.

A roundup of developments in corporate social responsibility and sustainability from the bio/pharmaceutical industry, its suppliers, and other public and private organizations.

Representatives from the United Nations, governments, businesses, and nonprofit groups met in Cancún, Mexico, to move forward international efforts for meeting climate-change goals.

The Global Health Progress collaboration works to improve healthcare delivery in the developing world.

The European Commission and Medicines Agency seem to be moving in advance of their ICH partners to update standards.

Expert and implementation working groups harmonize more guidelines and move Q11 forward.

Capable of great works, pharma as a whole still yields to the lesser angels of its nature.

AstraZeneca and Abbott End Program; PhRMA Elects New Members; and More.

Dr. Reddy's Laboratories (Hyderabad, Andhra Pradesh, India) has entered into a technology transfer, manufacturing, and marketing agreement with R-Pharm (Moscow), a Russian pharmaceutical company.

After five years of discussions, the US Food and Drug Administration is joining the Pharmaceutical Inspection Convention (PIC) and the Pharmaceutical Inspection Cooperation Scheme (PIC Scheme), known together as PIC/S.

The European Medicines Agency outlined it work program and budget for 2011 and anticipates similar work loads for drug applications and practically no increases to its budget for that work program in 2011.

The European Medicines Agency launched on December 20, 2010, a public registry about small and medium-sized enterprises (SME) that includes information about SME-registered companies.

Novartis (Basel) signed a memorandum of understanding with the City of St. Petersburg, Russia, confirming its intent to build a new full-scale pharmaceutical manufacturing plant in St. Petersburg.

Pfizer Recalls One Lipitor Lot; Sanofi Aventis Names Head of R&D; and More.

ICH Unveils New Website and Logo

A US Food and Drug Administration inspection completed on Dec. 9, 2010 revealed persistent deficiencies at McNeil Consumer Healthcare's Fort Washington, Pennsylvania, facility.

Thermo Fisher to Acquire Dionex; Former SOCMA CEO Joe Acker Dies; and More.

Abbott Laboratories (Abbott Park, IL), B. Braun Medical (Bethlehem, PA), and Roxane Laboratories, a subsidiary of Boehringer Ingelheim (Ingelheim am Rhein, Germany), agreed to pay the United States $421 million to settle False Claims Act allegations.