Angie Drakulich

Corporate management must be held accountable for quality at all levels.

FDA Commissioner Margaret Hamburg and US Assistant Secretary for Health Howard Koh released a statement aimed at a stakeholder meeting being held at the US Department of Health and Human Services to address the growing issue of drug shortages in the United States.

Deborah Autor testifies before US Senate HELP committee on requested authorities to improve pharma supply chain.

FDA's Division of Drug Marketing, Advertising, and Communication issued a letter to Pfizer's vice-president of US Regulatory Affairs regarding its online resources page for Lipitor tablets.

Clarifying GMPs for excipients used as actives.

USP and the Brazilian National Agency of Sanitary Surveillance are teaming up to develop joint education activities for professionals involved in formulating and using pharmacopeial monograph standards in Brazil.

FDA released a strategic plan to advance regulatory science on Aug. 17, 2011, in an effort to "keep pace with and utilize...new scientific advances," and to promote public health. The plan is based on the agency's five-year strategic goals and its October 2010 report on advancing regulatory science.

Since China's State Food and Drug Administration revised its GMPs last year, the agency has been making other improvements as well to improve the quality of its pharmaceutical manufacturing industry.

NIH leads new international consortium to develop a diagnostic tool for most known rare diseases by the year 2020.

FDA released this week a report from its Center for Drug Evaluation and Research (CDER) that identifies regulatory science needs that will guide CDER's strategic planning in the years ahead and allow it to fulfill its regulatory mission.

FDA issued a draft guidance for industry comment on proposed policy for diagnostic tests used with targeted drug therapies, that is personalized medicine.

FDA announced in early July 2011 that it has made progress toward implementing the US Food Safety Modernization Act, which was enacted in January of this year.

A new report places pharmaceutical and healthcare companies ahead in corporate and social governance.

GSK Works in Developing Nations to Improve Everything from Research to Roads.

FDA released a new strategy on that is aimed at meeting the challenges posed by rapidly rising imports of FDA-regulated products and the growing complexity of the pharmaceutical supply chain.

CDER Director Janet Woodcock announces reorganization.

A Focus on Creative Strategies to Help the Developing World.

Regulatory approvals for new biopharmaceuticals in the United States have nearly doubled in the past decade compared with the 1990s, says a Tufts study.

FDA is collecting public comments on a series of studies that the agency plans to conduct on online direct-to-consumer promotion of prescription drug products, according to an announcement in the Federal Register.

Regulators and standard-setting bodies are re-examining over-the-counter drugs.

FDA issued a draft guidance for industry on Mar. 11, 2011, titled User Fee Waivers, Reductions, and Refunds for Drug and Biological Products, that offers recommendations to applicants seeking such actions under the Federal Food, Drug, & Cosmetic Act (FD&C Act). A similar draft guidance was issued in July 1993. The new document clarifies the types of waivers, refunds, and reductions available under the user-fee provisions of the FD&C Act as well as the procedures for handling these requests, including how to appeal an FDA decision.

FDA announced on Mar. 2, 2011, that it is taking action against companies that manufacture, distribute, or market certain unapproved prescription oral cough, cold, and allergy products, according to an agency release.

Social media tools have taken over many aspects of our lives, now including regulatory info.

The United States Pharmacopeial Convention (USP) launched a 12-month pilot Technical Assistance Program (TAP) to provide developing countries in sub-Saharan Africa with greater capacity to test the quality of medicines.

The European Medicines Agency has released a new Annex 11-Computerized Systems to its GMP Guide Chapter 4 on Documentation to account for the increased use of and complexity of computerized systems in the drug-manufacturing community.

Industry and regulatory experts discuss the challenges and benefits of implementing real time release testing in a pharmaceutical manufacturing environment.

USP helps to improve drug quality in 32 countries.

A roundtable moderated by Angie Drakulich.

A contract-service provider roundtable, featuring Albemarle, Baxter, DPT, Pfizer CentreSource, Dr. Reddy's, SAFC, and Vetter. Read this and other preferred organization articles in this special issue.

FDA issued a draft guidance for industry on Jan. 18, 2011, about the size of beads within drug products labeled for sprinkle.