Coronavirus (COVID-19) Update: FDA Authorizes First Oral Antiviral for Treatment of COVID-19 - FDA.gov

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According to the article:

The "U.S. Food and Drug Administration issued an emergency use authorization (EUA) for Pfizer’s Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) for the treatment of mild-to-moderate coronavirus disease (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kilograms or about 88 pounds) with positive results of direct SARS-CoV-2 testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death. Paxlovid is available by prescription only and should be initiated as soon as possible after diagnosis of COVID-19 and within five days of symptom onset."

Read the full source article: Coronavirus (COVID-19) Update: FDA Authorizes First Oral Antiviral for Treatment of COVID-19 - FDA.gov

CDC Recommends One-Shot Johnson & Johnson COVID-19 Vaccine After FDA Authorizes Emergency Use - People

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According to the article:

"The vaccine from Johnson & Johnson is the third approved to fight the ongoing COVID-19 pandemic in the United States  ... 

Johnson & Johnson's COVID-19 vaccine has been approved for emergency use in the United States.

On Sunday, the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices voted to recommend the Johnson & Johnson vaccine to adults 18 years and older in the U.S., according to the Washington Post.

And on Saturday, the Food and Drug Administration (FDA) authorized the vaccine ... "

Read the full article:  CDC Recommends One-Shot Johnson & Johnson COVID-19 Vaccine After FDA Authorizes Emergency Use - People

FDA approves first two-drug complete regimen for HIV-infected patients who have never received antiretroviral treatment - FDA.gov

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Read the full press release:

FDA approves first two-drug complete regimen for HIV-infected patients who have never received antiretroviral treatment - FDA.gov

The U.S. Food and Drug Administration . . .

"approved Dovato (dolutegravir and lamivudine), as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults with no antiretroviral treatment history and with no known or suspected substitutions associated with resistance to the individual components of Dovato. This is the first FDA-approved two-drug, fixed-dose, complete regimen for HIV-infected adults who have never received treatment for HIV. 

“Currently, the standard of care for patients who have never been treated is a three-drug regimen. With this approval, patients who have never been treated have the option of taking a two-drug regimen in a single tablet while eliminating additional toxicity and potential drug interactions from a third drug,” said Debra Birnkrant, M.D., Director of the Division of Antiviral Products. “Having a drug-sparing treatment available that uses fewer drugs is beneficial to patients who may have issues taking multiple medications over a long period of time.”"

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FDA approves first autologous cellularized scaffold for the repair of cartilage defects of the knee - FDA.gov

Press Announcements > FDA approves first autologous cellularized scaffold for the repair of cartilage defects of the knee - FDA.gov:

"The U.S. Food and Drug Administration today approved Maci (autologous cultured chondrocytes on porcine collagen membrane) for the repair of symptomatic, full-thickness cartilage defects of the knee in adult patients. Maci is the first FDA-approved product that applies the process of tissue engineering to grow cells on scaffolds using healthy cartilage tissue from the patient’s own knee."

'via Blog this'


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FDA-approved hangover pill

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Updated May 11, 2024

Sadly, the link is now hiding behind a paywall.

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Cheers! FDA-approved hangover pill promises to take edge off holiday partying - NY Daily News:

"A new FDA-approved hangover cure has hit the market just in time for holiday party season."

'via Blog this'

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FDA withdraws approval of drug Avastin to treat breast cancer

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FDA withdraws approval of drug Avastin to treat breast cancer - latimes.com:

"Studies showed that women with advanced breast cancer taking Avastin had a higher risk of death from stroke or heart attack, and that the medication raised blood pressure and increased the risk of congestive heart failure. The risk of serious bleeding was five times higher among users of Avastin than it was for those on chemotherapy only."  'via Blog this'

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FDA Approves New Device - Screens for Melanoma

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Image via WikipediaUpdated 9/6/2013:

The original link broke.

You can still read about the same topic here:

New device uses light to screen for melanoma - NBC News

- - - - -

The Associated Press: New device uses light to screen for melanoma:    'via Blog this'

"The Food and Drug Administration (FDA) approved a first-of-its-kind device, called MelaFind, that makes detailed, digital images of skin growths and uses a computer to analyze them for signs of cancer, offering a sort of second opinion to doctors. The device is approved only for dermatologists and only for use on growths that don't have obvious signs of cancer but still have one or two worrisome traits."

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Should Mobile Medical Apps Require FDA Approval?

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Updated June 10, 2021

The links in the original post broke.

You can read more about this topic here:

Device Software Functions Including Mobile Medical Applications - FDA.gov

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Should Mobile Medical Apps Require FDA Approval? - Healthcare - Mobile and Wireless - Informationweek:  

Mobile Medical Apps Meet The FDA, Part 2 - Healthcare - Mobile and Wireless - Informationweek: 

A nice pair of articles, fairly and delicately balancing how much is enough, versus too much FDA regulation.

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FDA Controversy - Regen Biologic's Menaflex Device

The FDA is reassessing the safety of a device (Regen Biologic's Menaflex Device) that it previously approved for patients. The FDA conducted a March 23, 2010: Orthopaedic and Rehabilitation Devices Panel Meeting. Although the panel expressed that they would have liked to have seen more data on the device, they largely backed it as a safe and effective therapy.

The larger looming issue now is whether this will become precendent setting and raise the prospect of FDA re-evaluating previously approved devices.

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FDA Medical Device Controversies - Approvals and Clearance

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I thoroughly enjoyed reading this Health News Digest article, Is That Medical Device Safe And Effective? Who Knows? It's a great overview of:

• medical device classification
• premarket approval (PMA)
• premarket notification (510(k))
• substantially equivalent
• anecdotes that highlight controversies in the items above. This is the best part of the article.

For me, I get the sense that it's generally about business, and that some unethical companies might be putting our collective safety at risk.

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FDA Makes Zometa Inj Orange Book Decision

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Updated Dec 17, 2020
It's here! The latest Orange Book Annual Edition

You might also be interested in this webpage:
FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations


- -  original post below  - -

The Food and Drug Administration (FDA) has determined that ZOMETA (zoledronic acid for injection), equivalent to (EQ) 4 milligrams (mg) base/vial, lyophilized powder for injection, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for zoledronic acid lyophilized powder for injection, 4-mg base/vial. The Federal Register published the FDA docket "Determination That ZOMETA (Zoledronic Acid for Injection), Equivalent to 4 Milligrams Base Per Vial, Lyophilized Powder for Injection, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness (pdf)."

According to IP Pharma Doc's post, Zoledronic acid (ZOMETA) lyophilized powder for injection: USFDA confirmed that drug was not withdrawn due to safety issues, this decision will allow US FDA to approve ANDA's for the innovator's (Novartis) discontinued product (in May, 2003).

Kurt Karst posts an in-depth analysis and commentary related to the FDA decision, Attention Orange Book Junkies: FDA Petition Response Cements Orange Book Preface Therapeutic Equivalence Clarification.

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Avoid FDA 510k Medical Device Clearance Mistakes - 5 Free Tips

It's better to know what's needed upfront, than to get hung up at the last moment in the 510k process. "FDA medical device approval, also known as the FDA 510k process, can easily take much longer than anticipated due to common mistakes or omissions. Here are five tips to avoid some of those mistakes," reports Nicolaas Besseling in, "Five Tips for Quick FDA 510k Clearance for Medical Devices." In a nutshell . . .

1. Find out if the FDA regulates the device
2. Make sure the classification of the device is correct
3. Determine who will be the owner of the 510(k), and who will be the official correspondent
4. Use (a) predicate device(s) that is close to the new device
5. Pay close attention to the formatting of the submission

Following the 5 tips above won't necessarily guarantee success because there are many nuances and traps to avoid. If you're not expert in 510k filings, you might want to consider partnering with an industry consultant.

Related Posts:
Read Or Download The GAO Report - The FDA And High Risk Medical Devices (pdf)
FDA 510(k) Free Tips And Pearls Of Wisdom
Medical Devices - A murky 510(k) world?!

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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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Read Or Download The GAO Report - The FDA And High Risk Medical Devices (pdf)

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The FDA and medical device industry just got a wake-up call. Seems like this GAO report suggests greater rigor is needed in the premarket review process, MEDICAL DEVICES - FDA Should Take Steps to Ensure That High-Risk Device Types Are Approved through the Most Stringent Premarket Review Process. In any event, seems like this industry sector can expect potentially more rigorous regulation in the future . . . Bottomline, the reports states, "We are recommending that the Secretary of Health and Human Services direct the FDA Commissioner to expeditiously take steps to issue regulations for each class III device type currently allowed to enter the market through the 510(k) process. These steps should include issuing regulations to (1) reclassify each device type into class I or class II, or requiring it to remain in class III, and (2) for those device types remaining in class III, require approval for marketing through the PMA process." From your perspective, would more stringent regulation be a good thing? 

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FDA Final Guidance On Genetically Engineered Animals

The procedure of genetic engineering uses recombinant DNA for introducing new characteristics or traits into an animal. The new guidance, Guidance for Industry #187 - Regulation of Genetically Engineered Animals Containing Heritable Recombinant DNA Constructs, provides all the needed details, so that the producers of these animals will know what to do in order to get the FDA's approval. Moreover, producers of these animals will also have to follow the law and regulations of the National Environmental Policy Act. I think these are truly remarkable times in the life of scientific discovery. Do you find these advances astounding or troubling? 

More Information & Related Posts: From the FDA: Genetically Engineered Animals Say Maaah - Goats Make Anti-Clot Drug 

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FDA 510(k) Free Tips And Pearls Of Wisdom

Updated July 6, 2023

The original links broke.

You might also be interested in:

510(k) Clearances - FDA.gov

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If you're working on a 510(k) medical device submission, you might want to peek at this Medical Device Blog post that's full of great tips for avoiding heartaches, "510(k) Approval Timeline." There's some really good stuff there. Did you find those tips helpful? If you need more info, try the FDA's own site . . . The FDA's Information on Releasable 510(k)s: General Information Federal Register Notices Search the Releasable 510(k) Database Listing of CDRH Substantially Equivalent (SE) 510(k) Summaries or 510(k) Statements, for Final Decisions Rendered Downloadable 510(k) Files One gem is the FDA's "SCREENING CHECKLIST - ALL PREMARKET NOTIFICATION [510(k)] SUBMISSIONS" (free) that's used to assess whether your paperwork is complete enough or not for a substantive review. 

Previous 510(k) Posts: Medical Devices - A murky 510(k) world?! Medical Devices Containing Antimicrobial Agents - FDA Guidance Pending 

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Nice Review of US FDA Medical Device Regulation

This is an excellent introduction to, and review of the FDA's Medical Device Regulations. This report, "Review of U.S. Medical Device Regulation," published in the Journal of Medical Devices, highlights the differences between regulations guiding medical devices versus pharmaceuticals and underscores the complexity of the approval process and post-market surveillance administered by the Food and Drug Administration (FDA). The report tackles the subject in the following sub-topics . . .

1. Introduction
2. Regulatory Definition of Medical Devices
3. Risk-Based Device Classification
4. Safety and Effectiveness Requirements
5. Food and Drug Administration Programs/Regulatory Pathways
6. Quality Systems Regulation (QSR)
7. Regulation of Drug-Device Combinations (Combination Products)
8. Guidance Documents Available to the Device Industry
9. Conclusions

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The FDA Drug Approval Process - free video

Updated May 23, 2025

The original link broke.

You might also be interested in the following FDA video:

https://youtu.be/fZ-Msidi7EE?si=rzphqPYBxwWlPgxV

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For those of you wanting something a little more in-depth, here's this free 24 minute video, produced by peRX (prescribing evidence-based therapies), "Why and how are drugs approved?" Here's what the video presents . . .

1. Overview of drug research and development in the United States, and
2. The FDA drug approval process

A side note about peRX and this video. The peRX site states, "On May 13, 2004, Warner-Lambert, a division of Pfizer, Inc., entered into an Assurance of Voluntary Compliance/Discontinuance with the Attorneys General of 50 States and the District of Columbia to settle allegations that Warner-Lambert conducted an unlawful marketing campaign for the drug Neurontin® that violated state consumer protection laws. Among other things, the settlement provides for a $21 million Consumer and Prescriber Education grant program." The peRX Project is an educational program funded by the Consumer & Prescriber Education grant program.

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The FDA Drug Approval Process

Updated July 15, 2020

The link in the original post broke.

You might also be interested in this:
Development & Approval Process | Drugs (on the FDA.gov website)

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I always have to remind myself what's involved in getting a drug to market. This eSSORTMENT article is short, sweet, and a great overview of the process, "The FDA drug approval process - The FDA has an elaborate clinical process that examines new drugs for distribution to the public with its seal of approval." I've seen it stated in some other places I've read, that it can take about 15 years to 'birth' a new drug.

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