Continuous Manufacturing Has a Strong Impact on Drug Quality
By: Lawrence Yu, Ph.D. If we used a time machine to transport a pharmaceutical scientist from the 1960s into a current pharmaceutical production plant of today, it might be surprising to learn that they would already be very familiar with … Continue reading → (Source: FDA Voice)
Source: FDA Voice - April 13, 2016 Category: American Health Source Type: blogs
Developing a Consensus Voice: The Combination Products Policy Council
By: Nina L. Hunter, Ph.D., and Rachel E. Sherman, M.D., M.P.H. We recently announced the launch of lean process mapping to build a better system for combination products review – one that is more cohesive, more collaborative, more systematic, and … Continue reading → (Source: FDA Voice)
Source: FDA Voice - April 6, 2016 Category: American Health Source Type: blogs
FDA-State Partnership Propels FSMA Implementation
By: Michael R. Taylor and Stephen Ostroff, M.D. Ever since the FDA Food Safety Modernization Act (FSMA) was enacted in 2011, we’ve said that successful implementation is not possible without a meaningful partnership between FDA and its counterparts in state … Continue reading → (Source: FDA Voice)
Source: FDA Voice - March 31, 2016 Category: American Health Source Type: blogs
Priorities – Teamwork to Achieve Common Goals
By: Robert M. Califf, M.D. With my appointment as Commissioner of Food and Drugs comes a rare and humbling opportunity—to make a positive difference at an institution that does vitally important work for the nation and its citizens. During my … Continue reading → (Source: FDA Voice)
Source: FDA Voice - March 31, 2016 Category: American Health Source Type: blogs
Addressing Issues Relating to Combination Products: Human Factors
By: Jill Hartzler Warner, J.D., and Thinh Nguyen Combination products represent an important and growing category of therapeutic and diagnostic products under the FDA’s regulatory authority. These products, which combine a drug, device, and/or biological product (referred to as “constituent … Continue reading → (Source: FDA Voice)
Source: FDA Voice - March 25, 2016 Category: American Health Source Type: blogs
Border Crossings: Working With Partners to Verify the Safety of Imported Produce
By: Michael R. Taylor One of the vivid images that sticks with me from my tenure at FDA is of the port of entry at Nogales, Arizona. There, I saw large trucks from Mexico lined up as far as the … Continue reading → (Source: FDA Voice)
Source: FDA Voice - March 22, 2016 Category: American Health Source Type: blogs
FDA and NIH Release a Draft Clinical Trial Protocol Template for Public Comment
By: Peter Marks, M.D., Ph.D. Enhancing important efforts around clinical trials continues to be a key scientific priority. Another way we can encourage clinical trials is to look for ways to help clinical investigators make clinical trials more efficient, potentially … Continue reading → (Source: FDA Voice)
Source: FDA Voice - March 18, 2016 Category: American Health Source Type: blogs
A ‘Roadmap’ for Navigating Patient Advocacy
By: John J. Whyte, M.D., M.P.H. So, you and your organization have a passion for helping people and you want to work with FDA to advance your advocacy work. Are you unsure of the most effective way to enable patients … Continue reading → (Source: FDA Voice)
Source: FDA Voice - March 15, 2016 Category: American Health Source Type: blogs
FDA Unveils Multilingual Health Fraud Protection Initiative for Consumers
En Español By: Jonca Bull, M.D., and Jason Humbert, R.N. Consumers are constantly bombarded by advertisements for fraudulent medical treatments and cures — dangerous scams that often target the most vulnerable populations. FDA is fighting back with its own enhanced … Continue reading → (Source: FDA Voice)
Source: FDA Voice - March 11, 2016 Category: American Health Source Type: blogs
A FSMA Update for our Stakeholders in India
By: Howard Sklamberg In an effort to complement our conversations about the FDA Food Safety and Modernization Act (FSMA) in the United States, FDA is reaching out to our international partners and stakeholders to discuss implementation of this historic food … Continue reading → (Source: FDA Voice)
Source: FDA Voice - March 9, 2016 Category: American Health Source Type: blogs
‘Leaning in’ on Combination Products
By: Nina L. Hunter, Ph.D., and Rachel E. Sherman, M.D., M.P.H. Medical products that combine drugs, devices, and/or biological products are known as combination products. These products present a number of regulatory, policy, and review management challenges because they include … Continue reading → (Source: FDA Voice)
Source: FDA Voice - March 7, 2016 Category: American Health Source Type: blogs
Launching a New Natural History Grants Program: Building a Solid Foundation for Rare Disease Treatments
By: Katherine Needleman, Ph.D. and Gumei Liu, M.D., Ph.D. Today, on Rare Disease Day 2016, FDA’s Office of Special Medical Programs/Office of Orphan Products Development (OOPD) is proud to announce the launch of a new grants program to fund natural … Continue reading → (Source: FDA Voice)
Source: FDA Voice - March 1, 2016 Category: American Health Source Type: blogs
Have a Problem? Contact the New Ombudsman in the Office of Regulatory Affairs
By: Melinda K. Plaisier Whether we are inspecting your facilities, sampling your products, or conducting investigations, the primary goal of FDA’s Office of Regulatory Affairs (ORA) is to protect the public. But I understand the impact our actions can have … Continue reading → (Source: FDA Voice)
Source: FDA Voice - March 1, 2016 Category: American Health Source Type: blogs
Strengthening our Regulatory Relationships in India
By: Mathew T. Thomas and Dean Rugnetta India’s economic expansion is in part due to the tremendous growth in the pharmaceutical industry. The United States is a large consumer of medical products, and India is one of the largest suppliers … Continue reading → (Source: FDA Voice)
Source: FDA Voice - February 25, 2016 Category: American Health Source Type: blogs
A Closer Look at Tea and Rice: FDA Brings FSMA Outreach to Japan
By: Camille Brewer, M.S., R.D., and Sema Hashemi, M.S. Our delegation of FDA experts traveled to Tokyo and Osaka in the first week of February to hold seminars on our new final rules under the FDA Food Safety Modernization Act … Continue reading → (Source: FDA Voice)
Source: FDA Voice - February 23, 2016 Category: American Health Source Type: blogs
