FDA Law Blog: Mobile Medical Applications: A Thoughtful Guidance Is Finalized:
"The final guidance is similar to the draft guidance – but with improved clarity. Hence, it has expanded from 29 to 43 pages. Most of the additional pages are appendices with examples and other supplementary information. This guidance is sensible and well written."
Follow this link to the Mobile Medical Applications - FDA Guidance for Industry and Food and Drug Administration Staff (PDF)
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Showing posts with label draft. Show all posts
Showing posts with label draft. Show all posts
Friday, September 27, 2013
Friday, August 16, 2013
Medical Foods > FDA Draft Guidance for Industry: FAQs 2nd Ed
Medical Foods > Draft Guidance for Industry: Frequently Asked Questions About Medical Foods; Second Edition:
"The responses to these FAQs address common questions about the definition of and regulations for medical foods. This guidance is a second edition of the May 2007 guidance titled “Guidance for Industry: Frequently Asked Questions About Medical Foods.” This guidance provides responses to additional questions regarding the definition, labeling, and availability of medical foods and updates to some of the existing responses; new questions and answers and amended responses are identified by the date they were added to the guidance."
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Wednesday, July 17, 2013
FDA Draft Guidance Summarized: Delaying, Denying, Limiting, or Refusing a Drug Inspection
Updated November 4, 2020
Some the links broke in the original post below.
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- - - original post follows below - - -
" . . . in particular Section 707 of FDASIA, which added 501(j) to the FD&C Act, the FDA now deems as adulterated a drug that "has been manufactured, processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory, warehouse, or establishment delays, denies, or limits an inspection, or refuses to permit entry or inspection". (emphasis added)"
Read the draft guidance:
FDA - Draft Guidance for Industry - Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection (PDF)
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Monday, July 15, 2013
FDA Draft Guidance - Mobile Medical Apps - Practical Insights
Compliance Zen: Majority of Mobile Health Apps Class II Devices for FDA:
"FDA’s current draft guidance on mobile medical apps is woefully short of such practical specifics. And yet it’s these specifics that will get even the most forthright medical app developer in trouble with FDA-483s and Warning Letters. Warning Letters have been shown to reduce product sales by at least 8% the first year and for three years thereafter. For many of these developers, a Warning Letter might be the kiss of death and bring a painful chill to the innovation marketplace."
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Sunday, June 16, 2013
FDA Draft Guidance on Medical Device Cybersecurity
"This guidance provides recommendations to consider and document in FDA medical device premarket submissions to provide effective cybersecurity management and to reduce the risk that device functionality is intentionally or unintentionally compromised."
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Saturday, April 21, 2012
FDA issues draft guidance on nanotechnology
Updated June 25, 2023:
The original link broke.
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--- the original post follows below ---
Nanotechnology is an evolving technology that allows scientists to create, explore, and manipulate materials on a scale measured in nanometers – particles so small that they can not be seen with a regular microscope. The technology has a broad range of potential applications, such as the packaging of food or altering the look and feel of cosmetics.
Press Announcements - FDA issues draft guidance on nanotechnology:
The two draft guidance documents are: “Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes, including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, Including Food Ingredients that are Color Additives” and “Guidance for Industry: Safety of Nanomaterials in Cosmetic Products.”
The food draft guidance describes the factors manufacturers should consider when determining whether changes in manufacturing processes, including those involving nanotechnology, create a significant change that may:
- affect the identity of the food substance;
- affect the safety of the use of the food substance;
- affect the regulatory status of the use of the food substance; or
- warrant a regulatory submission to FDA.
The cosmetic product draft guidance discusses the FDA’s current thinking on the safety assessment of nanomaterials when used in cosmetic products. Key points include:
- The legal requirements for cosmetics manufactured using nanomaterials are the same as those for any other cosmetics. While cosmetics are not subject to premarket approval, companies and individuals who market cosmetics are legally responsible for the safety of their products and they must be properly labeled.
- To conduct safety assessments for cosmetic products containing nanomaterials, standard safety tests may need to be modified or new methods developed.
'via Blog this'
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Monday, January 30, 2012
FDA Supplement Guidance Not Strict Enough, MD Says
This is pretty controversial stuff, as the dietary supplement industry largely opposes the draft regulation
Medical News: FDA Supplement Guidance Not Strict Enough, MD Says - in Public Health and Policy, FDA General from MedPage Today:
"An FDA proposal to require dietary supplement manufacturers to submit data proving their product is safe doesn't go far enough, according to a physician writing in the New England Journal of Medicine.
More than 100 million Americans spend more than $28 billion on vitamins, minerals, herbal ingredients, amino acids and other natural products in the form of dietary supplements each year, "assuming they are both safe and effective," wrote Pieter A. Cohen, MD, of Harvard Medical School and the Cambridge Health Alliance.
But they have no assurance that the products are safe because FDA regulation of supplements is too weak, Cohen wrote in a Perspective piece."'via Blog this'
Read more about this:
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Wednesday, January 25, 2012
FDA issues first social media rules for drug companies
"The Food and Drug Administration is giving pharmaceutical companies some rules for how they interact with consumers on social media. But the companies say they need a lot more clarification from the FDA before they're comfortable getting back online again.
The draft guidance encourages all responses to unsolicited requests for information, which could include requests from physicians for information on off-label uses for certain drugs, to be made in a nonpublic format."'via Blog this'
Read this draft guidance:
FDA - Guidance for Industry - Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices (PDF)
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Monday, August 15, 2011
Medical Device Premarket Review - FDA Draft Guidance
The guidance focuses on premarket approval applications (PMAs), the regulatory pathway for high-risk medical devices. The recommendations made in the guidance are intended to improve the predictability, consistency and transparency of the premarket review process for applicable devices, and should help manufacturers navigate the approval process more easily.
In its review of PMAs, the FDA uses safety data and effectiveness data. The safety data addresses risk, and the manufacturer’s ability to mitigate that risk. The effectiveness data considers benefits, as well as other information, to determine whether the probable benefits outweigh the probable risks associated with use of the device.
Safety and effectiveness data alone may not provide a complete picture of the benefits and risks. FDA medical device reviewers objectively look at other factors such as the severity of the disease the product diagnoses or treats and whether or not alternative tests or treatments are available.
Device reviewers also may consider whether the device is new or a first-of-a-kind technology as part of the benefit-risk determination, particularly if the device treats a disease that has no other treatment.
The guidance also proposes that medical device reviewers use a worksheet to document how they make benefit-risk determinations. In certain cases, this document could be made public post-approval, making the FDA’s decision making process even more transparent.
Learn more:
FDA - Draft Guidance for Industry and Food and Drug Administration Staff - Factors to Consider when Making Benefit-Risk Determinations in Medical Device Premarket Review
Wednesday, July 20, 2011
FDA Issues Guidance For Mobile Medical Applications
Updated June 30, 2023
This topic has evolved over the years. Therefore, the original links broke.
You can still read about this same topic here:
--- the original post follows below ---
The U.S. Food and Drug Administration (FDA) announced it is seeking input on its proposed oversight approach for certain mobile applications specific to medicine or health care called mobile medical applications ("apps") that are designed for use on smartphones and other mobile computing devices. This approach encourages the development of new apps, focuses only on a select group of applications and will not regulate the sale or general consumer use of smartphones or tablets.
Today, mobile medical applications or "mobile medical apps," include a variety of functions, ranging from monitoring calorie intake, helping people maintain a healthy weight, and allowing doctors to view a patient’s radiology images on their mobile communications device. According to Research2Guidance 2010, 500 million smartphone users worldwide will be using a health care application by 2015.
"The use of mobile medical apps on smart phones and tablets is revolutionizing health care delivery," said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. "Our draft approach calls for oversight of only those mobile medical apps that present the greatest risk to patients when they don’t work as intended."
The agency’s draft guidance defines a small subset of mobile medical apps that impact or may impact the performance or functionality of currently regulated medical devices. This subset includes mobile medical apps that:
A. are used as an accessory to medical device already regulated by the FDA
(For example, an application that allows a health care professional to make a specific diagnosis by viewing a medical image from a picture archiving and communication system (PACS) on a smartphone or a mobile tablet); or
B. transform a mobile communications device into a regulated medical device by using attachments, sensors or other devices
(For example, an application that turns a smartphone into an ECG machine to detect abnormal heart rhythms or determine if a patient is experiencing a heart attack).
For more information:
FDA: Draft Guidance for Industry and Food and Drug Administration Staff – Mobile Medical Applications
FDA: Consumer Update - FDA Proposes Health 'App' Guidelines
FDA: Mobile Medical Applications
Monday, July 20, 2009
FDA Guidance on ANDA Drug Impurities
Updated October 11, 2020
The original link broke.
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- - - original post follows below - - -
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Wednesday, July 15, 2009
FDA Draft Guidance on Anti-Counterfeiting
“Drug counterfeiting is a serious public health concern,” said Commissioner of Food and Drugs Margaret A. Hamburg, M.D. “We look forward to working with industry to help ensure that consumers are not exposed to products containing unknown, ineffective, or harmful ingredients,” reports this FDA news release, FDA Issues Draft Guidance for Industry on Drug Anticounterfeiting - Focus on physical chemical identifiers. The U.S. Food and Drug Administration (FDA) today issued a draft guidance on the use of inks, pigments, flavors, and other physical-chemical identifiers (PCIDs) by manufacturers to make drug products more difficult to duplicate by counterfeiters, and to make it easier to identify the genuine version of the drug. This draft guidance is an important step in working with manufacturers to make drug products more difficult to duplicate by counterfeiters: Draft Guidance for Industry: Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting (pdf).
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FDA On Drug Counterfeiting
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Wednesday, June 17, 2009
FDA Draft Guidance on Injectors
To address the increasing popularity of drug-injector systems, the FDA (Food and Drug Administration) released a draft guidance, Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products.
The draft guidance applies to, but is not limited to, jet, pen, needle-free, and mechanically operated injectors as well as piston syringes and injectors with computerized or electronic elements. Injectors are categorized into three groups: those intended for use with a wide range of currently marketed drugs or biological products, those intended for use with a specific class or product line, and those intended for use with a specific product.
The FDA is providing this draft guidance document to assist industry in developing technical and scientific information to support a marketing application for a pen, jet, or related injector device intended for use with drugs and biological products. The marketing application would typically be a premarket notification submission (510(k)) or a premarket approval (PMA) application for the injector alone.
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Monday, January 26, 2009
FDA Draft Guidance - Accredited Labs - Submission Packages
The FDA Draft Guidance for Industry on Submission of Laboratory Packages by Accredited Laboratories is intended to enhance the quality and reliability of test results submitted by importers to demonstrate that their products meet the FDA's requirements. The guidance advises importers how to use accredited -- rather than non-accredited -- laboratories and makes recommendations about the quality and type of test data and information that these laboratories should produce in support of test results submitted to the FDA. The draft guidance is also intended to reduce the likelihood that an importer will select only favorable test results to submit to the FDA. This draft guidance supports the FDA's import strategy emphasizing prevention of harm, intervention when risks are identified, and rapid response after harm has occurred.
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FDA Draft Guidance On Good Importer Practices
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Thursday, January 22, 2009
FDA Draft Guidance - Drug Supply Chain and SNIs
Updated October 24, 2022:
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Wednesday, January 14, 2009
FDA Draft Guidance On Good Importer Practices
Updated October 6, 2022
Several links in the original post broke.
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--- the original post follows below ---
The guidance is designed to anticipate potential sources of product hazards and offer preventive controls that firms can implement to mitigate such hazards and help ensure imported products are safe and compliant with regulations. The draft is organized under 4 guiding principles . . .
- Establishing a product safety management program
- Knowing the product and applicable U.S. requirements
- Verifying product and company compliance with U.S. requirements throughout the supply chain and product life cycle
- Taking corrective and preventive action when the imported product is not in compliance with U.S. requirements
The draft guidance also recommends that:
- importers consider instituting practices to identify and minimize risks associated with imported products
- in general, importers should know the producer of the foreign products they purchase and any other manufacturers with which they do business, such as consolidators, trading companies, and distributors
- importers understand the products that they import and the vulnerabilities associated with these products
- importers understand the hazards that may arise during the product life cycle, including all stages of production, and ensure proper control and monitoring of these hazards
The agencies are issuing this draft guidance to implement recommendations outlined in the “Action Plan for Import Safety: A Roadmap for Continual Improvement,” issued by the Interagency Working Group on Import Safety, and to help foster a consistent approach by federal agencies and importers in ensuring the safety of products brought into the United States.
Related Posts: FDA Struggles To Keep Products From Foreign Sources Safe FDA Finds It Hard To Inspect Foreign Drug Manufacturing Plants
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Thursday, January 8, 2009
FDA Draft Guidance On Process Validation
The FDA recently released a draft guidance for new process validation. The guidance says that manufacturers would have to increase sampling and testing, and monitor process performance more closely during the early stages of commercial manufacturing, according to the FDA's Guidance for Industry - Process Validation: General Principles and guidance. Once finalized, this guidance replaces the FDA's process validation guidance issued in 1987. The new guidance applies to pharmaceuticals, biologics and active pharmaceutical ingredients. It will cover the 3 stages of process validation — process design, process qualification and continued process verification. Are you ready?
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View more FDA Guidance Documents (free)
FDA Draft Guidance On Proprietary Names
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New FDA Guidance - cGMP Practice for Phase 1 Investigational Drugs
FDA Guidance Documents - FDA Current Thinking (free)
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Monday, December 1, 2008
FDA Draft Guidance On Proprietary Names
Updated February 3, 2021
Unfortunately the links broke.
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- - - original post follows below - - -
This just released by the FDA, "Draft Guidance for Industry on the Contents of a Complete Submission for the Evaluation of Proprietary Names; Availability." This guidance, "provides recommendations to industry regarding the submission of a complete package that FDA intends to use to assess the safety of proposed proprietary drug and biological product names and other factors that, in association with the name, can contribute to medication errors. In addition, FDA intends to use this information in the assessment of promotional aspects of proposed proprietary names."
View more FDA Guidance Documents (free)
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