Guidances - A New & Better Way To Find FDA Guidance Documents

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Go to a new search page for FDA: Guidances - FDA.gov:

" . . . all official FDA Guidance Documents and other regulatory guidance. You can search for documents using key words, and you can narrow or filter your results by product, date issued, FDA organizational unit, type of document, subject, draft or final status, and comment period.

This feature is provided to give a convenient way to search for all FDA guidance documents from a single location. We will continue to refine it as we observe its performance."

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  Happy Holidays: FDA Moves to Ban Cake, Donut 'Sprinkles' - Breitbart

mHealth to see big growth, barriers | Healthcare IT News

mHealth to see big growth, barriers | Healthcare IT News:

"A new mobile health trends report released Wednesday underscores the mid- to low sophistication of current mHealth application technology but also emphasizes the explosive growth and integration headed for the market .

The Research and Markets mHealth trends report shows the industry poised for a compound annual growth rate of 61 percent by 2017, to reach a value of $26 billion. This revenue, researchers project, will be derived predominantly from mHealth hardware sales and services."

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New FDA Guidance - Cosmetic GMPs

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Updated July 22, 2021

The link in the original post broke.

Read more about the topic here:

Cosmetics Guidance Documents - FDA.gov

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Guidance Documents > Guidance for Industry: Cosmetic Good Manufacturing Practices:

" . . . as part of an international harmonization effort with the International Cooperation on Cosmetic Regulations (ICCR), FDA (or we) agreed to consider the current International Organization for Standardization (ISO) standard for cosmetic GMPs (ISO 22716:2007) when revising this guidance. We reviewed ISO 22716 and decided to incorporate, modify, or exclude specific aspects of it into this guidance based on our experience."

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Growing Anger Against The Pharmaceutical Industry

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We The People vs. The Pharmaceutical Industry - Forbes:

". . . All this adds up to a giant pushback against the astronomical drug prices that are becoming commonplace. It seems that price tags of $100,000 or above are becoming the norm. Of 12 cancer drugs approved in 2012, 11 cost more than that. As more drugs are offered at that level and their sponsors get away with it, it seems to set a floor that emboldens drug companies to push the envelope. They are badly misjudging the brewing anger. . . ."

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Bad Pharma - Book Review

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No doubt this will be a provocative read.  Follow the link to a comprehensive review of the book.

Science-Based Medicine » Bad Pharma: A Manifesto to Fix the Pharmaceutical Industry:

"Closing thoughts
This is a book with important messages for patients, health care professionals, governments, and the pharmaceutical industry. It may anger, and even infuriate you. It should. Yet Goldacre sketches out a path for reform – one in which transparency is the rule, not the exception, and one in which the pharmaceutical industry can engage with the health care system in ways that will help it do what we all want it to do – bring innovative new medications to market that improve the health and welfare of patients. This change, however, will only come when we demand better – better from pharmaceutical companies, better from regulators, and better from our fellow health professionals. Ultimately, we’ll have the industry we deserve – if we’re not willing to demand better, we’re never going to see any improvements. This book is your call to action."

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Order the book through Amazon.com:
Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients (Kindle Edition)

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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."

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Read more about this:

FDA Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues

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FDA issues first social media rules for drug companies

amednews: FDA issues first social media rules for drug companies : Jan. 25, 2012 ... American Medical News:

"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."

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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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Related articles

• Should Mobile Medical Apps Require FDA Approval? (drughealth.blogspot.com)

FDA Crackdown on Viagra-Like Supplements

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Updated November 12, 2020

Links broke in the original post.

You might also be interested in:  Tainted Sexual Enhancement Products - FDA.gov

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FDA Crackdown on Viagra-Like Supplements - Video - Bloomberg:

"The discovery came during a Food and Drug Administration inspection that’s part of an expanding crackdown by the agency on the $28 billion supplement industry."

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My gut sense tells me that this is just the tip of the iceberg, a problem of enforcement that the FDA will be hard pressed to wrap their arms around.

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Medical Device Premarket Review - FDA Draft Guidance

For the first time, the U.S. FDA (Food and Drug Administration) has provided draft guidance clarifying how benefit-risk determinations are made during premarket review of certain medical devices.

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

FDA - New Process Validation Guidance Document

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The FDA just published this, FDA - Guidance for Industry - Process Validation: General Principles and Practices (pdf).

In a nutshell, the CGMP regulations require that manufacturing processes be designed and controlled to assure that in-process materials and the finished product meet predetermined quality requirements and do so consistently and reliably.

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FDA Launches Website Explaining Food and Drug Regulations

It's a new year, and it's time to think about professional development goals for 2011.  You or your friends, family, or staff, might want to consider learning some of these FDA Basics:

FDA Basics for Industry  or
FDA Basics - Provides Information About FDA and What the Agency Does

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2011 Predictions - Congress and FDA-Regulated Industries

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Find out the answer on FDA Matters: The Grossman FDA Report (TM) - - - Will the New Congress Be Good for FDA-Regulated Industries?

Wishing you all the best in 2011!

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2011 - Global Pharma To Grow 5-7 Percent

2011, here we come.

IMS Health Forecasts Global Pharmaceutical Market Growth of 5-7 Percent in 2011, Reaching $880 Billion

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2011 Pharma Trends

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Updated March 12, 2022

The link in the original post broke.

You might also like:  Introducing the Pharma 2020 series - PWC.com

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It's that time of year again.

Brandon says, in Global Pharmaceutical Market Expected to Rebound in 2011:

• the global pharmaceutical market will experience 5% to 7% growth in the coming year, compared with only 4% to 5% in 2010.

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FDA Guidance - Impact Resistant Lenses - Q and A

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Guidance for Industry and FDA Staff - Impact-Resistant Lenses: Questions and Answers represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. As you read through the guidance, you'll find quite a number of useful hyperlinks to additional information and references.

Eyeglasses and sunglasses (eyewear) that are intended to affect the structure or function of the body or intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, are devices within the meaning of section 201(h) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 321(h)). These devices are subject to applicable device regulations under Title 21, Code of Federal Regulations. Impact-resistant lenses reduce the number of eye injuries from eyeglasses and sunglasses. Glass lenses, plastic lenses, or laminated glass lenses can be made impact resistant by any method. However, lenses generally must be capable of withstanding the impact test described in 21 CFR 801.410. This guidance answers questions for manufacturers, importers, and testing laboratories on such topics as test procedures, lens testing apparatus, record maintenance, and exemptions to testing.

This guidance is a revision of “Impact-Resistant Lenses: Questions and Answers (FDA 87-4002),” issued September 1987. This guidance updates answers to questions that industry and consumers frequently ask FDA about impact-resistant lenses and FDA regulation of eyewear. The revision reflects the exemption of sunglasses from the Premarket Notification (510(k)) requirement effective February 19, 1998 (21 CFR 886.5850(b)). The revised document also includes a more detailed discussion about lens blanks, semi-finished, finished, and plano lenses, as well as import procedures. The terms "eyeglasses" and "spectacles" are used interchangeably in this document.

Eyewear products regulated by FDA are commonplace in the daily lives of the vast majority of the general public. FDA believes that impact-resistant lenses are an essential component of the safe design of these devices.  The use of impact-resistant lenses in eyeglasses and sunglasses is addressed in 21 CFR 801.410.

For more information on this topic, contact the Division of Small Manufacturers, International, and Consumer Assistance (DSMICA) by phone at 1-800-638-2041, by fax at 301-847-8149, by e-mail at dsmica@fda.hhs.gov, or write to the following address:

U.S. Food and Drug Administration
Center for Devices and Radiological Health
Office of Communication, Education and Radiation Programs
Division of Small Manufacturers, International, and Consumer Assistance
10903 New Hampshire Ave.
WO66-4613
Silver Spring, Maryland 20993

#FDA #GMP #training #cGMP

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Cramer - Top 4 Healthcare Predictions for 2010

Image via Wikipedia

... rather, that's Cliff Cramer. In looking for 2010 trends, and predictions, I stumbled across his predictions, Top 4 Healthcare Predictions for 2010. It's the start of an interesting and provocative discussion of his 4 predictions (which I've truncated):

1. Multi-national pharmaceutical and medical technology companies will increase their investments in emerging markets.
2. Information technology will make greater strides in a healthcare industry.
3. Healthcare reform will continue across developed and developing markets.
4. Consolidation will be a major theme in 2010.

I recommend you go to his post, and jump into the discussion. On some gut level, I'm hoping the predictions ring true as my retirement investments will benefit.

Previous Posts: Biotechnology Trends 2010 - Free Report 

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Food Industry Ramifications of the FDA Cheerios Warning Letter

Sarah Sunday writes this excellent legal opinion explaining the background and ramifications of the FDA's warning letter to the makers of Cheerios, Is FDA Warning Letter An Ominous Signal To Food Industry? This is all about the FDA objecting to the statement that Cheerios can lower cholesterol levels. In a nutshell, she says:

"FDA's Warning Letter is a slap on the wrist in terms of the potential regulatory consequences. However, the letter could have a significant legitimizing effect on the pending California lawsuit, and in that way, could have costly implications for both General Mills and the food industry as a whole."

Previous Posts: And The Top 10 Food Stories Of 2008 Pet Food Sickened People - Did they eat it? . . . Time To Talk About Turkey Cooking and Food Safety FDA CFSAN - Food Safety and Nutrition Video Library (free) 

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FDA Guidance - FDA and Sponsor-Applicant Meetings

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Updated October 24, 2022

The original link broke.

There are many FDA guidance documents intended for meetings between the FDA and Sponsors or Applicants.

You can find them by searching the FDA website:

Search for FDA Guidance Documents - FDA.gov

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This FDA guidance, Guidance for Industry Formal Meetings Between the FDA and Sponsors or Applicants, provides recommendations to industry on formal meetings between the Food and Drug Administration (FDA) and sponsors or applicants relating to the development and review of drug or biological drug products (hereafter products) regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). This guidance does not apply to abbreviated new drug applications. For the purposes of this guidance, formal meeting includes any meeting that is requested by a sponsor or applicant following the request procedures provided in this guidance and includes meetings conducted in any format (i.e., face to face, teleconference, or videoconference). This guidance discusses the principles of good meeting management practices (GMMPs) and describes standardized procedures for requesting, preparing, scheduling, conducting, and documenting such formal meetings. The general principles in this guidance may be extended to other nonapplication-related meetings with external constituents, insofar as this is possible. This guidance supersedes the guidance for industry Formal Meetings With Sponsors and Applicants for PDUFA Products published February 2000. The 2000 guidance implemented section 119(a) of the Food and Drug Administration Modernization Act of 1997, and reflected a unified approach to all formal multidisciplinary meetings between sponsors or applicants and the FDA. 

Related Posts: Cheerios Aside . . . FDA Gives Guidance On OTC Labels (pdf) FDA Draft Guidance - Drug Supply Chain and SNIs FDA Final Guidance On Genetically Engineered Animals FDA Draft Guidance On Good Importer Practices FDA Guidance Documents - FDA Current Thinking (free) 

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Free Intro To Biomedical Engineering (videos)

Updated August 26, 2024

The structure of the Academic Earth site has changed.

You can find many of the mentioned classes, through their search function.

Here's one search, using "biomedical engineering" to get you started:

https://academicearth.org/?s=biomedical+engineering

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This is a collection of free video lectures by Mark Saltzman of Yale, hosted on the Academic Earth website. He covers basic concepts of biomedical engineering and their connection with the spectrum of human activity. His lectures serve as an introduction to the fundamental science and engineering on which biomedical engineering is based. Case studies of drugs and medical products illustrate the product development-product testing cycle, patent protection, and FDA approval. It is designed for science and non-science majors. This should be of some interest to those in the biotech, drug, and medical device industries. Here's the list of his free video lectures: Lecture 1 - What Is Biomedical Engineering? Lecture 2 - What Is Biomedical Engineering? (cont) Lecture 3 - Genetic Engineering Lecture 4 - Genetic Engineering (cont) Lecture 5 - Cell Culture Engineering Lecture 6 - Cell Culture Engineering (cont) Lecture 7 - Cell Communication and Immunology Lecture 8 - Cell Communication and Immunology (cont) Lecture 9 - Biomolecular Engineering: Engineering of Immunity Lecture 10 - Biomolecular Engineering: Engineering of Immunity (cont) Lecture 11 - Biomolecular Engineering: General Concepts Lecture 12 - Biomolecular Engineering: General Concepts (cont) Lecture 13 - Cardiovascular Physiology Lecture 14 - Cardiovascular Physiology (cont) Lecture 15 - Cardiovascular Physiology (cont) Lecture 16 - Renal Physiology Lecture 17 - Renal Physiology (cont) Lecture 18 - Biomechanics and Orthopedics Lecture 19 - Biomechanics and Orthopedics (cont) Lecture 20 - Bioimaging Lecture 21 - Bioimaging (cont) Lecture 22 - Tissue Engineering Lecture 23 - Tissue Engineering (cont) Lecture 24 - Biomedical Engineers and Cancer Lecture 25 - Biomedical Engineers and Artificial Organs 

Related Posts: Structural Aspects of Biomaterials - More than 20 free video lectures 

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FDA Draft Guidance On Proprietary Names

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Updated February 3, 2021

Unfortunately the links broke.

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Best Practices in Developing Proprietary Names for Human Prescription Drug Products - Guidance for Industry - FDA.gov (PDF)

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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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