Blog Posts - Fda



CONGRESS - I the FDA Getting a Funding Increase?

"Major health bill would fund medical research, hasten FDA approvals" PBS NewsHour 12/6/2016ExcerptSUMMARY:  In Congress, lawmakers are close to passing a major bill that would increase funding for the FDA, the NIH, and the effort to fight opioi...
by Mage Soapbox on Dec 12, 2016

Cancer Quotes for You

October marches on, and in keeping with Cancer Awareness Month, I bring you the following quotes mostly from M.D.s about cancer, its treatment and the AMA & FDA’s consistent effort to keep non-toxic and effective solutions away from America...
by Nutritional Truths on Oct 14, 2016

FDA Amends List of Drugs that May Not Be Compounded

The Food and Drug Administration (FDA) announced that it is amending regulations to revise the list of drugs that have been withdrawn or removed from the market because the drug products or their components have been found to be unsafe or ineffective...
by Pharmaceutical Microbiology on Oct 11, 2016

FDA - Periodic Benefit Risk Evaluation Report (PBRER)

U.S. FDA has produced a new guidance document, titled “E2C (R2) Periodic Benefit Risk Evaluation Report (PBRER) - Guidance for Industry.”When a new medicinal product is approved for marketing, demonstration of safety and efficacy are generally ba...
by Pharmaceutical Microbiology on Sep 14, 2016

HEALTHY HISPANIC BABIES - Folic Acid

"Health advocates score a major victory with folic acid" PBS NewsHour 4/14/2016ExcerptSUMMARY:  The Food and Drug Administration announced Thursday that it would allow folic acid to be added to corn flour in order to prevent certain types of bir...
by Mage Soapbox on Apr 18, 2016

The FTC’s Tool for Mobile Health App Developers

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FDA Guide for Microbial Vectors used for Gene Therapy

New FDA draft guidance issued, titled “FDA Guide for Microbial Vectors used for Gene Therapy.”The introduction reads:“We, FDA, are providing you, investigational new drug application (IND) sponsors, with recommendations concerning IND submissio...
by Pharmaceutical Microbiology on Jan 10, 2016

“Pharma Bro” – Lessons Learned

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“Pharma Bro” – Lessons Learned

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BIG PHARMA - Extra Strength Tylenol Regulation

"New Court Docs: Maker of Tylenol Had a Plan to Block Tougher Regulation" by Jeff Gerth and T. Christian Miller, ProPublica 9/21/2015Filings from a lawsuit, scheduled to go to trial today in Atlantic City, describe a previously unreported lobbying ca...
by Mage Soapbox on Sep 22, 2015

FDA - Changes for General Safety Test

The Food and Drug Administration (FDA) is amending the biologics regulations by removing the general safety test (GST) requirements for biological products. FDA is finalizing this action because the existing codified GST regulations are duplicative o...
by Pharmaceutical Microbiology on Sep 4, 2015

Endotoxin Testing Recommendations for Single -Use Intraocular Ophthalmic Devices

FDA has issued a new guidance document of interest, titled "Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices."The introduction reads:"This guidance document was developed to notify manufacturers of the recommended...
by Pharmaceutical Microbiology on Sep 1, 2015

Inquiry Roundup-Drug Formulation

Regional Drug Delivery Device Require an expert with extensive knowledge of regional drug delivery device markets to help identify suppliers who can manufacture electronic drug delivery devices (smart inhalers, nebulizers,... Read More The...
by Zintro Blog on Aug 7, 2015

Supplemental Measures to Enhance Duodenoscope Reprocessing

The FDA has issued a safety communication to further help reduce the risk of infection transmission associated with duodenoscope use.  In this communication, the FDA recommends health care facilities performing endoscopic retrograde cholangiopan...
by Pharmaceutical Microbiology on Aug 7, 2015

August 2015 Gilenya Label Change About PML Brain Infection Follows FDA Drug Safety Alert About This Serious Side Effect

These Two PML Cases Did Not Involve The Patients Previously Using The MS Drug Tysabri, As Did The One Which FDA Reported In August 2013 (Posted by Tom Lamb at DrugInjuryWatch.com) On August 4, 2015 the FDA posted on its web site this Safety Alert, &q...
by Drug Injury Watch on Aug 6, 2015

FDA - Reportable CMC Changes for Approved Drug and Biologic Products

FDA has issued a new guidance document: “Established Conditions: Reportable CMC Changes for Approved Drug and Biologic Products - Guidance for Industry.”This guidance describes those sections in a common technical document (CTD)- formatted applic...
by Pharmaceutical Microbiology on Jul 29, 2015

FDA Releases Dozens of New Bioequivalence Recommendations, Including for Sovaldi

FDA Releases Dozens of New Bioequivalence Recommendations, Including for Sovaldi Posted 29 June 2015By Alexander Gaffney, RAC A new batch of bioequivalence recommendations issued by the US Food and... Monday HCV News Ticker- Hepatitis C: Coffee, Me...
by HCV New Drug Research on Jun 30, 2015

CHOLESTEROL - Powerful New Class of Drugs

"Powerful new class of cholesterol drugs offers hope for some patients" PBS NewsHour 6/10/2015ExcerptSUMMARY:  More than 30 million Americans take statins to lower their cholesterol, according to estimates.  But these popular drugs don't wo...
by Mage Soapbox on Jun 15, 2015

Multiple Myeloma Drug Pomalyst Associated With Side Effects Risks Of Cardiac Failure, Interstitial Lung Disease, And Hepatotoxicity

In May 2015 The Medicines and Healthcare Products Regulatory Agency In UK Issued A Drug Safety Update; Will There Be Similar FDA Action? (Posted by Tom Lamb at DrugInjuryWatch.com) Pomalidomide (brand name: Pomalyst in the US; Imnovid in Europe) is a...
by Drug Injury Watch on Jun 3, 2015

With Zofran - Birth Defects Lawsuits Filed, How Will GlaxoSmithKline Update Its Drug Label To Comply With New FDA Rule Effective June 2015

New FDA Rule Requires Drug Company To Replace Current Simple Pregnancy Category Designation With A Summary Of The Risks Of Using Zofran During Pregnancy (Posted by Tom Lamb at DrugInjuryWatch.com) Starting earlier this year drug injury products liabi...
by Drug Injury Watch on Apr 29, 2015


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