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The FDA on April 3 issued this safety alert following at least 35

The FDA on April 3 issued this safety alert following at least 35

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FDA investigates reports of seizures after vaping

Likelihood of Subsequent Safety-Related Event for Drugs Approved in the Last 2 Months before the Review Deadline as Compared with Drugs Approved in the ...

Figure 3. Likelihood of Subsequent Safety-Related Problem for Drugs Approved in the Last 2 Months before the Review Deadline as Compared with Drugs Approved ...

Settlements in FCA Matters Relating to Patient Assistance Programs

Settlements in FCA Matters Relating to Patient Assistance Programs

Drug Shortages, 2010- 2015. Drug safety monitoring

Number of FCA Settlements

Actions Related to FDA Oversight of Compounding Facilities after Passage of the Drug Quality and Security Act.

A. False Claims Act

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2018 FSBP Premiums

Safety-Related Events for Drugs Approved Just before the Review Deadline and for Drugs Approved at Any Other Time in the Review Process, 1993–2004.

FDA MedWatch: E-cigarette: Safety Communication - Related to Seizures. The FDA on April 3 issued this safety alert following at least 35 ...

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Antibiotic-Contaminated Shrimp Rejections Make Up Nearly One-Quarter of the FDA's Seafood Entry

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FDA MedWatch: E-cigarette: Safety Communication - Related to Seizures. Seizures prompt FDA to issue e-cigarette warning The FDA on April 3 ...

Gibson Dunn | 2016 Mid-Year FDA and Health Care Compliance and Enforcement Update - Drugs and Devices

A warning was issued by the U.S. Consumer Product Safety Commission (CPSC) about the

After counterfeit Avastin®—what have we learned and what can be done? | Nature Reviews Clinical Oncology

Criteria for Making an Investigational Drug Available through an Expanded-Access Program, According to Type of Use.

Generic drugs face quality, safety questions

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CDC, FDA issue E. coli warning about chopped romaine lettuce

An example of a warning letter the FDA sent to a CBD products company making health claims

FDA Approves Fast-Acting Esketamine for Treatment-Resistant Depression

Table 3. Features of Existing “Right-to-Try” Laws in Three States.

Farewell Commissioner Gottlieb

FDA, CDC Announce Massive Recall of Fresh Cut Melon Over Salmonella Outbreak Concerns

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SGLT inhibitors for people with type 1 diabetes - Practical DiabetesPractical Diabetes ?

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(Reproduced from Center for Drug Evaluation and Research of the FDA, Application number 125294Orig1s000.)

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The FDA's Broad Authority Allows It to Take Additional Actions that May Indirectly Lower Prescription Drug Prices

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Warning issued over romaine lettuce after another E coli outbreak spreads

Some E-cigarette Users Are Having Seizures, Most Reports Involving Youth and Young Adults. CTP Special Announcement. The FDA ...

Visual Abstract - Latex: A Lingering and Lurking Safety Risk

At least that's how the public comment process works.

FDA Foreign Facility Inspections conducted Fiscal Year (FY) 2010 through June 30, 2016 (GAO-17-143)

FDA investigates possible seizure risk from vaping

Pill bottles

Table 1 Reported studies on non-medical switching from re-ETN to SB4 biosimilar in real-life clinical studies

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Table 7 Summary of changes made to labeling and IFU based on the formative and validation studies

Warning: People ignore warning labels

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Biodistribution and persistence of LEISHDNAVAX following single and multiple i.d. injections. Groups of 10 Wistar rats (5 male, 5 female) were injected once ...

Data Analysis

The FDA has identified at least four bars -- KIND Fruit & Nut Almond

Keeping our Members Informed

Drug ads include a lot of warnings — probably too many, FDA says

Curt Merlo, special to ProPublica

Distribution of Approvals According to Month of Review Cycle before and after Implementation of the Prescription Drug User Fee Act (PDUFA).

ZTlido® (lidocaine topical system 1.8%) is based on a novel and proprietary technology and contains only 36 mg of lidocaine but delivers the same amount of ...

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Mylan headquarters at Southpointe in Washington County.

Psych News Alert

“Request to Connect” – A New Way for Patients to Connect with FDA. “

Download Accord Gemcitabine Compare PDF

Bernadette Tansey, "Hard Sell: How Marketing Drives the Pharmaceutical Industry/The Side Effects of Drug Promotion/Aggressive Ads for Painkillers Left More ...

Section 4 –Product Information

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FDA Sounds Alarm on Dangers of Antacid Drugs

Figure 1. Latex Exposure Events and Near Miss Events by Care Area (N =

The GetSafe wall buttons are a nice addition to their in-home medical alert package

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Schedule I blocks cannabis research, feds admit (Newsletter: April 3, 2019) | Marijuana Moment

Table 1 User needs and their resolution during device design

The number of novel devices approved or cleared by CDRH has increased steadily from 24 in

Antidiabetic drugs marketed in the US in the period 1980–2015 with boxed warnings,

Data Mining Techniques in Pharmacovigilance: Analysis of the Publicly Accessible FDA Adverse Event Reporting System (AERS) | IntechOpen

Biocon Ltd, Bangalore, India FDA Inspection History (October 1, 2008 to December 13, 2017)

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In 2018, as in prior years, the most prevalent legal theory among health care provider settlements was that the provider had billed government health ...

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From our first leader, George Washington, to the latest, Donald Trump, our presidents have been no strangers to the importance of intellectual property.

Medical device dangers: FDA facing criticism over missed signs

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Putting up holiday decorations is a ritual many families look forward to all year; although there is no national collection of data on the subject, ...

Gelesis Granted FDA Clearance to Market PLENITY™ - a New Prescription Approach to Weight Management

As pharma companies underwrite three-fourths of the FDA's budget for scientific reviews, the

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Fresh BlueKeep Warning Issued by Microsoft: Public Exploits Exist and Attacks Imminent

NOTES: The first patient was treated in March 2013 and the first approval was November 2015.

Hospitals and device makers still struggle to rid medical scopes of infectious bacteria

Sample Medication-Use Process Map for an Intravenous Antineoplastic Drug