Angie Drakulich

The FDA plans to hold a public hearing to discuss the promotion of agency-regulated drugs and medical devices using the internet and social media tools.

The US Food and Drug Administration plans to hold a public hearing to discuss the promotion of agency-regulated drugs and medical devices on the Internet and using social media tools, according to a notice in the Sept. 21, 2009, Federal Register.

After introducing the concept of the FDA as a public health agency earlier this year with FDA Commissioner Margaret Hamburg, the FDA's Principal Deputy Commissioner, Joshua M. Sharfstein, has now outlined four principles that define the agency's role.

Speaking to the audience of the 2009 PDA-FDA Joint Regulatory Conference in Washington, DC, this week, US Food and Drug Administration Principal Deputy Commissioner outlined four principles that define FDA's role as a public health agency.

The 2009 PDA-FDA Joint Regulatory Conference opened this morning in Washington, DC, with a keynote address by Dr. Joshua Sharfstein, principal deputy commissioner at the US Food and Drug Administration.

The FDA plans to begin collecting information for its Sentinel Initiative, according to Federal Register announcement.

The US Food and Drug Administration plans to begin collecting information for its Sentinel Initiative, according to a Sept. 4 Federal Register announcement.

Barbara Jentges, the Managing Director at PhACT GmbH, a regulatory consulting and training firm in Switzerland, speaks about changing regulatory expectations — with a focus on Europe.

Later this month, Dr. Barbara Jentges, the managing director at PhACT GmbH, a regulatory consulting and training firm based in Duggingen, Switzerland, will be speaking at the 2nd Vetter Drug Management Leadership Conference in Germany.

As new process validation guidelines emerge, industry needs to reinvent how it releases product.

The FDA has said it would like to amend postmarket safety reporting regulations ?to require that manufacturers and other facilities subject to current reporting requirements submit their reports in an electronic format".

The US Food and Drug Administration announced in an Aug. 20, 2009 release that it would like to amend postmarket safety reporting regulations "to require that manufacturers and other facilities subject to current reporting requirements submit their reports in an electronic format."

The FDA has announced a new programme regarding the issuance of warning letters to the pharmaceutical industry.

The US Food and Drug Administration announced a new program regarding the issuance of warning letters to the pharmaceutical industry.

A new industry consortium of pharmaceutical manufacturers and their suppliers addresses supply-chain integrity, including possible approaches to shared supplier audits.

The US Food and Drug Administration announced its prescription drug user fee rates for fiscal year 2010 in the August 3 Federal Register.

Industry is taking a step forward by addressing supply-chain integrity through the formation of Rx-360. PhamTech's podcast explores the subject.

A summary of recent changes to European regulatory requirements for pediatric formulations.

Two years ago, the US Food and Drug Administration's Office of Generic Drugs (OGD) developed and implemented a program to test question-based reviews for abbreviated new drug applications (ANDAs). OGD is reviewing the benefits and challenges faced by pharmaceutical firms involved in the initiative to see what changes need to be made going forward.

The US Food and Drug Administration issued a draft guidance for industry, Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting, on July 13.

The European Commission adopted the final report on its anticompetitive inquiry into the pharmaceutical sector on July 8, 2009.

The National Institutes of Health (NIH) issued on July 7, 2009, final guidelines for human stem-cell research that widen the door to the cell lines that can be used if they meet certain ethical requirements.

Roche has officially withdrawn from the Pharmaceutical Research and Manufacturers Association (PhRMA) after being a member for 36 years.

The regulators are doing it. But industry's fear of sharing information may leave them behind.

Former Senator Majority Leaders Howard Baker, Tom Daschle, and Bob Dole released a report this month, Crossing Our Line: Working Together to Reform the US Health System, which proposes four pillars of health reform.

Last week, the steering committee and expert working groups of the International Conference on Harmonization met in Yokohama, Japan, to discuss pending guidelines and other relevant issues.

The US Food and Drug Administration released a new guidance for industry, Medication Guides-Adding a Toll-Free Number for Reporting Adverse Events, on June 8, 2009.

The International Serious Adverse Event Consortium (SAEC), a nonprofit partnership, has helped the US Food and Drug Administration gain significant understanding of the genetic basis for drug-induced liver injury, according a new FDA press release.

The US Food and Drug Administration posted a draft guidance for industry, Presenting Risk Information in Prescription Drug and Medical Device Promotion, on its website May 26, that describes factors the agency considers when evaluating advertisements and promotional labeling for prescription drugs and medical devices.

Last week, the US District Court in Concord, New Hampshire, sentenced 63-year-old Robert McFadden, an attorney from Palm Springs, CA, to three years of incarceration to be followed by two years of supervised release for participating in the purchase and distribution of the HIV drug Serostim (somatropin recombinant), according to a US Department of Justice press release.