NEWS | Provision FDA Consulting Group

2 days ago

FDA Approves First Extended-Release, Injectable Drug Regimen for Adults Living with HIV

On January 21, The U.S. Food and Drug Administration approved Cabenuva (cabotegravir and rilpivirine, injectable formulation) as a comple...

Over 300 COVID-19 Tests and Collection Kits Authorized by the FDA in 2020

Provision Consulting Group

Jan 15

Over 300 COVID-19 Tests and Collection Kits Authorized by the FDA in 2020

Recently, the FDA revealed traces of their fiercest battle against the COVID-19 pandemic last year. "Our Center for Devices and Radiologi...

The Most Commonly Reported Side Effects of Pfizer-BioNTech COVID-19 Vaccine

Provision Consulting Group

Dec 29, 2020

The Most Commonly Reported Side Effects of Pfizer-BioNTech COVID-19 Vaccine

On December 11, 2020, the U.S. Food and Drug Administration issued the first emergency use authorization (EUA) for a vaccine for the prev...

FDA authorizes Pfizer, First COVID-19 Vaccine in the United States

Provision Consulting Group

Dec 16, 2020

FDA authorizes Pfizer, First COVID-19 Vaccine in the United States

On December 11, 2020, FDA authorized the first EUA (Emergency Use of Authorization) for a vaccine for COVID-19) for individuals 16 years ...

The Basic Information about Face Masks, Surgical Masks, and Respirators

Provision Consulting Group

Dec 4, 2020

The Basic Information about Face Masks, Surgical Masks, and Respirators

There is an outbreak of respiratory disease caused by a novel coronavirus called “Coronavirus Disease 2019” (COVID-19) and it raised shor...

FDA authorizes first fully at-home COVID-19 test kit

Provision Consulting Group

Nov 18, 2020

FDA authorizes first fully at-home COVID-19 test kit

The Food and Drug Administration has authorized emergency use of the first at-home coronavirus test, which gives results back in about 30...

Pfizer COVID Vaccine 90 Percent Effective in Trials, Company May Request EUA by the End of November

Provision Consulting Group

Nov 12, 2020

Pfizer COVID Vaccine 90 Percent Effective in Trials, Company May Request EUA by the End of November

On Monday Pfizer announced that its coronavirus vaccine developed with BioNTech SE prevented 90 % of infections in a trial with tens of t...

Hand Sanitizer in Food Pouch is Recalled

Provision Consulting Group

Oct 5, 2020

Hand Sanitizer in Food Pouch is Recalled

Photo Courtesy of Nikki Teixeira, by Katie Kindelan, ABC News Last September, a mom in Canada was warning parents and caregivers after sh...

FDA Introduces A New OTC Monograph User Fee Program (OMUFA)

Provision Consulting Group

Sep 17, 2020

FDA Introduces A New OTC Monograph User Fee Program (OMUFA)

On March 27, 2020, the President signed the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) to aid response efforts and ea...

FDA Provides Guidance to Industry for Detecting and Preventing Nitrosamines in Drugs

Provision Consulting Group

Sep 4, 2020

FDA Provides Guidance to Industry for Detecting and Preventing Nitrosamines in Drugs

Since the outset of our discovery of impurities called nitrosamines in some types of drugs more than two years ago, the U.S. Food and Dru...

FDA Announces Advisory Committee Meeting to Discuss COVID-19 Vaccines

Provision Consulting Group

Sep 2, 2020

FDA Announces Advisory Committee Meeting to Discuss COVID-19 Vaccines

The U.S. Food and Drug Administration announced that a public meeting of the Vaccines and Related Biological Products Advisory Committee w...

FDA Broadens EUA for Veklury to Include All Hospitalized Patients for Treatment of COVID-19

Provision Consulting Group

Sep 2, 2020

FDA Broadens EUA for Veklury to Include All Hospitalized Patients for Treatment of COVID-19

On August 28, as part of its ongoing efforts to fight COVID-19, the U.S. Food and Drug Administration broadened the scope of the existing...

FDA Medical Device User Fees Increase 7% for 2021 Fiscal Year

Provision Consulting Group

Aug 19, 2020

FDA Medical Device User Fees Increase 7% for 2021 Fiscal Year

FDA medical device user fees of both standard rates and small-business rates will slightly increase for 2021 fiscal year, which is Octobe...

FDA Issues EUA to Yale for SalivaDirect, A New Method of Saliva Sample Process

Provision Consulting Group

Aug 18, 2020

FDA Issues EUA to Yale for SalivaDirect, A New Method of Saliva Sample Process

On August 15, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) to Yale School of Public Health for its S...

FDA Permits First Game-Based Digital Therapeutic to Improve Attention Function in Children with ADHD

Provision Consulting Group

Aug 7, 2020

FDA Permits First Game-Based Digital Therapeutic to Improve Attention Function in Children with ADHD

On June 15, the U.S. Food and Drug Administration (FDA) permitted marketing of the first game-based digital therapeutic device to improve...

FDA Authorizes First Tests that Estimate a Patient’s Antibodies from Past SARS-CoV-2 Infection

Provision Consulting Group

Aug 7, 2020

FDA Authorizes First Tests that Estimate a Patient’s Antibodies from Past SARS-CoV-2 Infection

On July 31, the U.S. Food and Drug Administration authorized the first two COVID-19 serology tests that display an estimated quantity of ...

FDA Reissues EUA Revising Which Types of Respirators Can Be Decontaminated for Reuse

Provision Consulting Group

Aug 1, 2020

FDA Reissues EUA Revising Which Types of Respirators Can Be Decontaminated for Reuse

In response to public health and safety concerns about the appropriateness of decontaminating certain respirators, the agency is reissuin...

FDA recalls hand sanitizer products that have tested positive for methanol contamination

Provision Consulting Group

Aug 1, 2020

FDA recalls hand sanitizer products that have tested positive for methanol contamination

FDA is warning consumers and health care providers that the agency has seen a sharp increase in hand sanitizer products that are labeled ...

Another FDA study shows the body absorbs chemicals in sunscreen products

Provision Consulting Group

Aug 1, 2020

Another FDA study shows the body absorbs chemicals in sunscreen products

Before slathering on sunscreen by the pool or on the golf course, consider this -- another study suggests you could be injecting chemica...

How You Can Make a Difference During the Coronavirus Pandemic

Provision Consulting Group

Jul 13, 2020

How You Can Make a Difference During the Coronavirus Pandemic

Image Source: https://www.fda.gov/consumers/consumer-updates/how-you-can-make-difference-during-coronavirus-pandemic

{"items":["600b595471276b0017e12f99","5ff8edfd0c1bcb0017588f47","5fe3ee47b1d6a8001703578c","5fd95d38518811001797f3da","5fac54359592f60017edd504","5fb5a17bf17e490017719f64","5fac88336ec9d50017998cc6","5f7b7e3f556f3100177bcf23","5f629220e146090017fa7f1e","5f52cecd9168910018796ed5","5f4fef9c9bd2bd001730d5fe","5f4fe8c17b58ea0017f2d9c7","5f3c5c2bfec94e0017845c5f","5f3c58eabfd99f0017f5074a","5f2ce83896528e001774a46a","5f2ce56516f0ce00175cf6c0","5f24b7781385630017d51679","5f24b37efb965900177cdb13","5f24b20706721d00171d13c7","5f0bfa46fdf2ba001733ff46"],"styles":{"galleryType":"Columns","groupSize":1,"showArrows":true,"cubeImages":true,"cubeType":"fill","cubeRatio":1.3333333333333333,"isVertical":true,"gallerySize":30,"collageAmount":0,"collageDensity":0,"groupTypes":"1","oneRow":false,"imageMargin":32,"galleryMargin":0,"scatter":0,"rotatingScatter":"","chooseBestGroup":true,"smartCrop":false,"hasThumbnails":false,"enableScroll":true,"isGrid":true,"isSlider":false,"isColumns":false,"isSlideshow":false,"cropOnlyFill":false,"fixedColumns":1,"enableInfiniteScroll":true,"isRTL":false,"minItemSize":50,"rotatingGroupTypes":"","rotatingCropRatios":"","columnWidths":"","gallerySliderImageRatio":1.7777777777777777,"numberOfImagesPerRow":1,"numberOfImagesPerCol":1,"groupsPerStrip":0,"borderRadius":0,"boxShadow":0,"gridStyle":1,"mobilePanorama":false,"placeGroupsLtr":false,"viewMode":"preview","thumbnailSpacings":4,"galleryThumbnailsAlignment":"bottom","isMasonry":false,"isAutoSlideshow":false,"slideshowLoop":false,"autoSlideshowInterval":4,"bottomInfoHeight":0,"titlePlacement":"SHOW_ON_THE_RIGHT","galleryTextAlign":"center","scrollSnap":false,"itemClick":"nothing","fullscreen":true,"videoPlay":"hover","scrollAnimation":"NO_EFFECT","slideAnimation":"SCROLL","scrollDirection":0,"scrollDuration":400,"overlayAnimation":"FADE_IN","arrowsPosition":0,"arrowsSize":23,"watermarkOpacity":40,"watermarkSize":40,"useWatermark":true,"watermarkDock":{"top":"auto","left":"auto","right":0,"bottom":0,"transform":"translate3d(0,0,0)"},"loadMoreAmount":"all","defaultShowInfoExpand":1,"allowLinkExpand":true,"expandInfoPosition":0,"allowFullscreenExpand":true,"fullscreenLoop":false,"galleryAlignExpand":"left","addToCartBorderWidth":1,"addToCartButtonText":"","slideshowInfoSize":200,"playButtonForAutoSlideShow":false,"allowSlideshowCounter":false,"hoveringBehaviour":"NEVER_SHOW","thumbnailSize":120,"magicLayoutSeed":1,"imageHoverAnimation":"NO_EFFECT","imagePlacementAnimation":"NO_EFFECT","calculateTextBoxWidthMode":"PERCENT","textBoxHeight":0,"textBoxWidth":200,"textBoxWidthPercent":50,"textImageSpace":10,"textBoxBorderRadius":0,"textBoxBorderWidth":0,"loadMoreButtonText":"","loadMoreButtonBorderWidth":1,"loadMoreButtonBorderRadius":0,"imageInfoType":"ATTACHED_BACKGROUND","itemBorderWidth":1,"itemBorderRadius":0,"itemEnableShadow":false,"itemShadowBlur":20,"itemShadowDirection":135,"itemShadowSize":10,"imageLoadingMode":"BLUR","expandAnimation":"NO_EFFECT","imageQuality":90,"usmToggle":false,"usm_a":0,"usm_r":0,"usm_t":0,"videoSound":false,"videoSpeed":"1","videoLoop":true,"jsonStyleParams":"","gallerySizeType":"px","gallerySizePx":940,"allowTitle":true,"allowContextMenu":true,"textsHorizontalPadding":-30,"itemBorderColor":{"value":"rgba(0, 0, 0, 0.25)"},"showVideoPlayButton":true,"galleryLayout":2,"targetItemSize":940,"selectedLayout":"2|bottom|1|fill|true|0|true","layoutsVersion":2,"selectedLayoutV2":2,"isSlideshowFont":false,"externalInfoHeight":0,"externalInfoWidth":0.5},"container":{"width":940,"galleryWidth":972,"galleryHeight":0,"scrollBase":0,"height":null}}