FDA has released the latest edition of the Director's Corner podcast. Listen to Dr. Woodcock discuss the new FAERS public dashboard tool, which makes FAERS data easier to query and retrieve. She discusses the advantages of the tool as well as its limitations. Click on the following links to read a transcript and listen to the podcast.
The U.S. Food and Drug Administration launched a new user-friendly search tool that improves access to data on adverse events associated with drug and biologic products through the FDA’s Adverse Event Reporting System (FAERS). The new FAERS public dashboard enables users to search for and organize data by criteria such as drug/biological product, age of the patient, type of adverse event, year the adverse event occurred, or within a specific timeframe.
For the first time, the FDA is posting a new report that provides a list of the drugs that entities registered as outsourcing facilities have produced. Under the Drug Quality Security Act (DQSA), outsourcing facilities are required to report to the FDA, upon initial registration and each June and December, the drug products that they compounded during the previous six months.
The FDA’s publication Approved Drug Products with Therapeutic Equivalence Evaluations, commonly referred to as the “Orange Book,” includes information about patents or exclusivities that apply to a particular drug product approved under the Federal Food, Drug, and Cosmetic Act (the Act). Patents and exclusivities are two different forms of protection for qualifying drug products that may affect how and when certain generic versions of those drug products are approved.
To read more, please visit: CDER Conversations.
new efforts to encourage compounding of better quality drugs under DQSA and help health care professionals access compounded medications needed for patient care from outsourcing facilities. Read more
Manufacturing of drugs has become increasingly complex and global, requiring us to remodel our oversight of these tasks, to improve FDA’s efficiency and reach. As a step toward achieving these goals, FDA previously announced that we’re restructuring our field activities, to direct our focus and organization around the programs we regulate, instead of our previous structure, that organized our activities and resources based on geographic regions. This allows us to better align the expertise of our staff and make more efficient use of our resources.
FDA is announcing the availability of a revised draft guidance for industry entitled “Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products.” The last few decades have seen an increasing demand in various health care settings for solid oral dosage form drug products repackaged into unit-dose containers, which hold a quantity of drug for administration as a single dose. The increase in unit-dose repackaging has led to questions regarding stability studies and appropriate expiration dates for these repackaged products. This revised draft guidance describes the conditions under which FDA does not intend to take action regarding required stability studies for these repackaged products and the expiration date to assign under those conditions. Through this notice, FDA is hoping to decrease the regulatory burdens of drug regulations on manufacturers of these products, while at the same time ensuring patient safety.
We’re at a point in science where new medical technologies hold out the promise of better treatments for a widening number of vexing conditions. Over the last few decades, science has enabled fundamental advances in our understanding of the genetic and protein bases of human disease. These developments are already being translated into new medicines. In more cases, these treatments target the underlying mechanisms that drive different diseases. These advances hold out the promise of arresting and even curing a growing number of diseases.
Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy Guidance for Industry
Today the FDA took two important new steps to encourage generic drug development and increase generic drug access:
These actions are part of Commissioner Gottlieb’s recently announced Drug Competition Action Plan, and follow the announcement of next month’s public meeting on administering the Hatch-Waxman Amendments. The agency plans to take additional, related actions in the near future, and will continue to communicate with stakeholders as these new elements are implemented.
As part of the work by the Federal Government to address the epidemic of prescription and illicit opioid abuse, the FDA is announcing a public workshop to obtain input on issues and challenges associated with Federal efforts to support training on pain management and the safe prescribing, dispensing, and patient use of opioids (safe use of opioids) for health care providers. As discussed in this document, the workshop has three main goals. First, participants will be asked to discuss the role that health care provider training plays, within the broader context of ongoing activities, to improve pain management and the safe use of opioids. Second, participants will be asked to comment on how best to provide health care providers, who prescribe or are directly involved in the management or support of patients with pain, appropriate training in pain management and the safe use of opioids. Finally, participants will be asked about the issues and challenges associated with possible changes to Federal efforts to educate health care providers on pain management and the safe use of opioids. More information
This LIVE extended webinar format, with Q&A sessions, is intended to provide a deeper look at REMS, focusing on two topics:
Reducing preventable harm from medications is a big part of FDA’s mission. It requires teamwork across all of health care and the medication manufacturing, distribution, and delivery system.Reducing preventable harm from medications is a big part of FDA’s mission. It requires teamwork across all of health care and the medication manufacturing, distribution, and delivery system.
Watch FDA’s new video, Definition of a Drug video.
Whether a product is regulated as a drug, a cosmetic, or both under the law is determined by a product's intended use. FDA Drug Info Rounds pharmacists discuss the key differences between a drug and a cosmetic.
Just over three years ago, Congress amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) by enacting the Drug Quality and Security Act (DQSA). The first title of the DQSA, known as the Compounding Quality Act, was passed in response to numerous serious adverse events, including deaths, linked to poor quality compounded drugs. Since enactment of the DQSA, FDA has worked diligently to mitigate the public health risks associated with compounded drugs by conducting inspections and taking appropriate regulatory and enforcement actions, developing policies, convening advisory committee meetings, collaborating and coordinating with the states, and conducting stakeholder outreach.
The Food and Drug Administration’s Office of Generic Drugs (OGD) has now posted its 2016 annual report. 2016 marked the highest number of generic drug approvals and tentative approvals ever awarded by OGD–more than 800. These generic drug products have the potential to provide more affordable care to thousands of patients with serious and life-threatening diseases. OGD continues to improve its review infrastructure, meet all Generic Drug User Fee Amendments (GDUFA) commitments, and promote consistency across all applications.
Direct link to the report: https://go.usa.gov/xXqRz
The Food and Drug Administration will hold a public meeting of the Pharmaceutical Science and Clinical Pharmacology (PSCP) Advisory Committee. The committee will discuss strategies, approaches, and challenges in model-informed drug development for new and generic drugs.
The PSCP Advisory Committee meeting will be held at the Omni Shoreham Hotel, the Ballroom, 2500 Calvert St. NW, Washington, DC 20008 on March 15, 2017, from 7:30am to 3:45pm. The Advisory Committee meeting will be held in conjunction with the American Society for Clinical Pharmacology and Therapeutics 2017 Annual Meeting.
Meeting materials will be available prior to the meeting
Talking with Kathryn Aikin, Ph.D., who is a Senior Social Science Analyst and Research Team Lead in the Office of Prescription Drug Promotion, Office of Medical Policy, CDER.
In the past, prescription drug makers typically marketed their drugs only to health care professionals. In the 1980s and early 1990s, companies began to market their products to consumers through direct-to-consumer (DTC) ads, via both print and broadcast media. The Guidance for Industry on Consumer-directed Broadcast Advertisements (finalized in 1999), clarified how a company may fulfill the “adequate provision” obligation for broadcast ads. This obligation stated that, in addition to including important risk information, broadcast ads should describe the sources a consumer can use to find complete prescribing and risk information for the drug.
DDI Webinar Series: Collaborating with FDA - Get Involved with FDA’s MedWatch Adverse Event Reporting Program
Will be held on: February 7, 2017 Time: 1:00 pm to 2:00 pm (EST)
To register for the online meeting, please visit: https://collaboration.fda.gov/ddi020717/event/registration.html After registering, you will receive a calendar invitation with details on how to join the online meeting.
FDA announced the release of two guidances related to medical product communications and reopened the comment period for the off-label Public Hearing. For more information about this release, please see the Statement from FDA Commissioner Robert Califf, M.D.
The guidances and information on the comment period for the off-label public hearing can be found at:
FDA issued a document titled, “FDA’s Human Drug Compounding Progress Report: Three Years After Enactment of the Drug Quality and Security Act.”
This report provides a brief overview of the history of drug compounding regulation, as well as FDA’s regulatory oversight of drug compounders, implementation of the compounding provisions of federal law, and state and stakeholder collaboration since enactment of the Drug Quality and Security Act on November 27, 2013. It also discusses the need for ongoing efforts to protect patients from the risks associated with compounded drug products that are not produced in accordance with applicable requirements of federal law, while preserving access to lawfully-marketed compounded drugs for patients who have a medical need for them.
The Food and Drug Administration released a summary of novel drugs approved by the agency’s Center for Drug Evaluation and Research (CDER) in calendar year 2016 as new molecular entities or as new therapeutic biologics. Novel drugs are often innovative products that serve previously unmet medical needs potentially adding significant clinical value to the care of thousands of patients – many with serious and life-threatening diseases. While the quantity of novel drug approvals decreased in 2016, our focus continues to be on the unique medical value of many of these new drugs, their contribution to enhanced patient care, and the various regulatory tools the Agency employed to ensure their safe and efficient development and approval.
Listen to Dr. Woodcock discuss the FDA's actions to implement the Opioid Action Plan, including important safety labeling changes.
The portion of this guidance that describes when manufacturers should notify FDA if there is a high risk that a product is illegitimate, is being distributed for comment purposes only.
The FDA recently published an infographic on drug shortages
The Food and Drug Administration (FDA) is announcing a public workshop to be held on February 2, 2017, entitled “Ninth Annual Sentinel Initiative Public Workshop.” Convened by the Duke-Margolis Center for Health Policy at Duke University and supported by a cooperative agreement with the FDA, this 1-day workshop will bring the stakeholder community together to discuss a variety of topics on active medical product surveillance.
An allegation of regulatory misconduct is a claim that a medical device manufacturer or individuals marketing medical devices may be doing so in a manner that violates the law. Reporting these allegations can help make the FDA aware of regulatory concerns it may not learn of otherwise. This information can help the FDA identify the potential risks to patients and determine whether further investigation is warranted, as well as any steps needed to address or correct a potential violation.
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As FDA works to address the opioid epidemic of abuse, misuse and addiction, it’s valuable to see firsthand some of the ways the crisis is affecting our communities.
See Blog Post
The FDA has proposed a rule that would amend the list of drug products that may not be compounded under certain sections of the Food, Drug, and Cosmetic that provide for marketing of compounded drugs because they have been withdrawn or removed from the market for safety or effectiveness reasons. The proposed rule is open for comment for 75 days.
The public comment period for the proposed rule will be open for 75 days. For information on how to submit comments to the public docket, see the notice in the Federal Register.
Please see the statement FDA's website for more information.
This workshop will:
Did you know that you can report problems that you have had with drugs and other medical products to the FDA? Did you know that MedWatch can send safety alerts directly to you, as soon as they appear on the web site? The featured speaker, Cristina Whalen Klafehn PharmD, BCPS, CDE, a Health Programs Coordinator in FDA’s Office of Health and Constituent Affairs will give an overview of the program, including recent updates, on the reporting of adverse events to the FDA.
For more information and program slides, please visit: FDA Basics Webinar.
FDA announces safety labeling change (SLC) data on the Web will now be available in real time for health care providers, health information technology vendors, and the public to view, search, and download. Ultimately, the FDA expects that prompt access to these vital safety data by health care providers and consumers will better promote patient health.
The FDA MedWatch program posted safety labeling changes monthly to the FDA MedWatch web site and sent an email link to all subscribers of the MedWatch email list by the 15th of the month. The Drug Safety Labeling Changes (SLC) database provides approved safety labeling changes from January 2016 forward. Data prior to July 2016 will continue to be available on the MedWatch website
Please visit the database to obtain the most recent label changes:
The U.S. Food and Drug Administration (FDA) today launched an improved web-based version of the Approved Drug Products with Therapeutic Equivalence Evaluations – most commonly known as the “Orange Book.” This is the first major revision of the web page and features an updated design with new, user-friendly search options that help users customize their research experience.
The redesigned Orange Book web page conveniently collects search and browse options onto the home page to improve access of these commonly used features. Groups of “accordion” panels open to reveal new and enhanced features and contact information.
The Orange Book, which identifies drug products approved on the basis of safety and effectiveness by the FDA, first appeared as a published list in October 1980. Since 1984, the Orange Book has also included information about patents and exclusivity for listed products. In 1997, the FDA made the Orange Book database available for searching on the Web. Today, “Orange Book” is one of the most searched-for terms on FDA.gov.
The FDA issued draft guidance on insanitary conditions at compounding facilities. The draft guidance is intended to assist compounding facilities in identifying insanitary conditions so they can implement appropriate corrective actions. It is also intended to assist state regulatory agencies in understanding some examples of what FDA considers to be insanitary conditions.
The FDA also posted a statement on the draft guidance.
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