First Major FSMA Compliance Dates: Landmarks and Learning Experiences
By: Stephen Ostroff, M.D., and Howard Sklamberg, J.D. The phrase “where the rubber meets the road” is one that comes up in conversations about different subjects, from athletics to academics, when carefully laid plans are put to a crucial test. … Continue reading → (Source: FDA Voice)
Source: FDA Voice - September 20, 2016 Category: American Health Source Type: blogs
Evaluating FDA ’s Approach to Cancer Clinical Trials
By: Richard Pazdur, M.D. Since the announcement of the FDA Oncology Center of Excellence (OCE) two months ago (June 29, 2016) as part of the White House’s Cancer Moonshot, we’ve been working to further FDA’s efforts to get new oncology … Continue reading → (Source: FDA Voice)
Source: FDA Voice - September 16, 2016 Category: American Health Source Type: blogs
FDA and Access to Medications
By: Janet Woodcock, M.D. A severe allergic reaction called anaphylaxis is a medical emergency that affects the whole body and, in some cases, leads to death. If you have had an anaphylaxis episode, you always face the risk of another … Continue reading → (Source: FDA Voice)
Source: FDA Voice - September 14, 2016 Category: American Health Source Type: blogs
On Dauphin Island, FDA Scientists Work to Keep Seafood Safe
By: Capt. William Burkhardt III, Ph.D. On a barrier island in the Gulf of Mexico, two dozen scientists and staff in the FDA’s only marine research laboratory have one common goal: to keep consumers safe from contaminated or unsafe seafood. … Continue reading → (Source: FDA Voice)
Source: FDA Voice - September 14, 2016 Category: American Health Source Type: blogs
FDA Cooperative Agreements with States to Advance Food Safety
By: Stephen Ostroff, M.D. Today, the FDA is honoring an important commitment by awarding millions of dollars to the states that will help implement the new produce safety rule mandated by the FDA Food Safety Modernization Act (FSMA) to protect … Continue reading → (Source: FDA Voice)
Source: FDA Voice - September 10, 2016 Category: American Health Source Type: blogs
FDA Is Preparing Guidances that Will Help Food Companies Prevent Foodborne Illness
By: Susan Mayne, Ph.D., and Tracey Forfa, J.D. When we were drafting and seeking public comment on the rules that will implement the FDA Food Safety Modernization Act (FSMA), we promised that we would do whatever we could to help … Continue reading → (Source: FDA Voice)
Source: FDA Voice - August 24, 2016 Category: American Health Source Type: blogs
Making Continuous Improvements in the Combination Products Program: The Pre-RFD Process
By: Thinh Nguyen and Rachel E. Sherman, M.D., M.P.H. One question that sponsors often ask FDA is whether their medical product will be regulated as a drug, a device, a biologic, or as a combination product, and in the case … Continue reading → (Source: FDA Voice)
Source: FDA Voice - August 11, 2016 Category: American Health Source Type: blogs
FDA Supports Greater Access to Naloxone to Help Reduce Opioid Overdose Deaths
By: Karen Mahoney, M.D. Overdose deaths involving prescription opioids such as oxycodone, hydrocodone and morphine and illicit opioids such as heroin and illegally produced fentanyl have more than tripled since 1999 – with about 28,000 people dying in 2014 alone. … Continue reading → (Source: FDA Voice)
Source: FDA Voice - August 10, 2016 Category: American Health Source Type: blogs
FDA Working to Keep the U.S. Blood Supply Safe from Zika and other Emerging Threats
By: Peter Marks, M.D., Ph.D., and Luciana Borio, M.D. Each day in the United States, thousands of people receive transfusions of blood or blood products as part of their medical treatment. Although such transfusions can save lives, like most medical … Continue reading → (Source: FDA Voice)
Source: FDA Voice - August 9, 2016 Category: American Health Source Type: blogs
Protecting the Public and Especially Kids from the Dangers of Tobacco Products, Including E-Cigarettes, Cigars and Hookah Tobacco
By: Mitch Zeller, J.D. This month, for the first time, FDA will be able to help protect the public, and especially kids, from the dangers of all tobacco products. For years, it has been illegal under federal law to sell … Continue reading → (Source: FDA Voice)
Source: FDA Voice - August 9, 2016 Category: American Health Source Type: blogs
FDA Working to Keep the U.S. Blood Supply Safe from Emerging Threats
By: Peter Marks, M.D., Ph.D., and Luciana Borio, M.D. Each day in the United States, thousands of people receive transfusions of blood or blood products as part of their medical treatment. Although such transfusions can save lives, like most medical … Continue reading → (Source: FDA Voice)
Source: FDA Voice - August 6, 2016 Category: American Health Source Type: blogs
Piloting an Improved Intercenter Consult Process
By: Michael Rappel, Ph.D., and Rachel E. Sherman, M.D., M.P.H. Over the last few months, we’ve shared what FDA is doing to improve the review of combination products, including establishing the Combination Product Council and identifying necessary process improvements through … Continue reading → (Source: FDA Voice)
Source: FDA Voice - August 2, 2016 Category: American Health Source Type: blogs
The Unique Voices of Our Patient Representatives
By: Robert M. Califf, M.D., and Heidi C. Marchand, Pharm.D. We recently met with 21 inspirational patients and patient caregivers who have made the extraordinary commitment to become FDA patient representatives. These volunteers were in Washington to participate in our … Continue reading → (Source: FDA Voice)
Source: FDA Voice - July 29, 2016 Category: American Health Source Type: blogs
Leveraging the Power of Collaboration – FDA ’s New Oncology Center of Excellence
By: Richard Pazdur, M.D. I am honored to be selected by Commissioner Califf today as the acting director of FDA’s new Oncology Center of Excellence (OCE) in support of the Vice President’s National Cancer Moonshot Initiative. This new center will … Continue reading → (Source: FDA Voice)
Source: FDA Voice - July 21, 2016 Category: American Health Source Type: blogs
Practical Applications of FDA Regulations for the Indian Food Industry
By: Dean Rugnetta Globalization of the food supply chain and advances in food processing technologies have led American consumers to develop a taste for a variety of foods and cuisines from different countries. Increasingly, U.S. grocery stores sell foods from … Continue reading → (Source: FDA Voice)
Source: FDA Voice - July 21, 2016 Category: American Health Source Type: blogs
