Angie Drakulich

FDA talks about the changing scope of regulatory science.

Our editorial advisory board members provide their perspective on what's ahead in the biopharmaceutical industry.

A recent ISPE guidance provides a baseline for the design of quality laboratory facilities.

Keeping tabs on crucial medicines should be part of consumers' and manufacturers' emergency-preparedness plans.

Global coordination tactics that incorporate online technologies and social media are reshaping disease prevention and response.

NECC gets 483 after fungal meningitis outbreak.

At this week's AAPS 2012 Annual Meeting in Chicago, graduate students across the country are being honored for their research and work in bio/pharmaceutical innovation. BioPharm International had the chance to talk with a few of the recipients.

Will the next US President support the backbone of our industry?

Although FDA cannot do anything to stop drugs from being discontinued, it can do something about supply and quality problems that lead to shortages.

The Pharmaceutical Research and Manufacturers of America and Biotechnology Industry Organization released statements last week regarding the Senate's vote to pass the Food and Drug Administration Safety and Innovation Act, which reauthorizes PDUFA.

ICH Q11, the anticipated guideline from the International Conference on Harmonization, titled Development and Manufacture of Drug Substances, has achieved international consensus. Q11 has been one of the fastest guidelines to move through the ICH harmonization process.

FDA issued a final rule on sterility testing on May 3 which amends the requirements for most licensed biological products and aims to provide manufacturers with the flexibility, as appropriate, to keep pace with technological and scientific advances. Many steps are changed or eliminated.

No matter the time or cost, knowing what's going on inside your facilities is always going to be worth the effort.

This month, CDER added a new program in drug safety to its "CDER World" platform for regulatory training and education.

Johnson & Johnson announced this week that Sheri S. McCoy, vice-chairman of the Executive Committee, has resigned from the company. She was considered to be in line for the CEO position, being filled by Alex Gorsky.

The National Institute for Bioprocessing Research and Training (NIBRT) in Ireland and Waters are partnering on training and research to increase large-molecule characterization capacity and knowledge, according to an NIBRT press release.

FDA has issued a list of planned draft and final guidance documents for release throughout 2012.

Representatives from leading CROs weigh in on key challenges tied to the biopharmaceutical R&D, including issues regarding bioequivalence, platform technologies, process analytics, and more.

Has the long-awaited guidance answered all of the industry's questions?

Industry announces plans for year ahead at annual JPMorgan Global Healthcare Conference.

The benefits of harmonization may be on industry's wish list, but buying into change is another story.

Government plans require investment, partnership, and industry collaboration.

FDA Commissioner Margaret Hamburg and US Assistant Secretary for Health Howard Koh released a statement on Sept. 9, 2011, aimed at a stakeholder meeting held at the US Department of Health and Human Services (HHS) to address the growing problem of drug shortages in the United States. The shortages affect many necessary drugs, including those for cancer, anesthesia, influenza, and other critical conditions.

FDA?s Division of Drug Marketing, Advertising, and Communication (DDMAC) issued a letter to Pfizer?s vice-president of US Regulatory Affairs regarding its online resources page for Lipitor (atorvastatin calcium) tablets. The letter, which was brought about as part of the agency?s Bad Ad program, cites that the webpage is misleading because it makes representations and/or suggestions about the efficacy of Caduet (amlodipine besylate/atorvastatin calcium) tablets, Chantix (varenicline) tablets, and Norvasc (amlodipine besylate) tablets without communicating risk information associated with the use of these drugs.

The US Pharmacopeia (USP) continues to expand its collaboration with drug authorities around the world, this time with Brazil?s regulatory agency. USP and the Brazilian National Agency of Sanitary Surveillance (ANVISA) are teaming up to develop joint education activities for professionals involved in formulating and using pharmacopeial monograph standards in Brazil, according to news releases on the USP website.

Inside the National Institutes of Health

Since China?s State Food and Drug Administration (SFDA) revised its GMPs last year (they became effective Mar. 1, 2011), the agency has been making other improvements to enhance the quality of its pharmaceutical manufacturing industry. Many improvements are tied to the 2015 deadline SFDA has placed on existing domestic drug manufacturers to implement the revised guidelines. Newly created companies are expected to meet the new GMPs from the start.

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. The report, Identifying CDER?s Science and Research Needs, discusses internal research initiatives and goals for contributing to the agency?s overall regulatory science efforts.

In early July 2011, FDA provided an update in which the agency said that it has made progress toward implementing the US Food Safety Modernization Act (FSMA), which was enacted in January 2011. In addition to clarifying expectations for new dietary ingredients through new draft guidance, the agency has issued an antismuggling strategy.

At last week?s 2011 Partnering for Global Health Forum, sponsored by the Biotechnology Industry Organization and BioVentures for Global Health, a unique panel of government leaders from emerging markets discussed what it takes to do business in their countries.