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Human Drugs

Generic Drug Competition Lowers Prices: FDA Analysis

An updated FDA analysis shows that an increase in generic drug competition leads to a decrease in generic drug prices.

Medical Devices

Medical Device Tax Repealed

A $1.4 trillion federal spending bill includes repeal of the medical device tax imposed under the Affordable Care Act and other provisions sought by t...

Human Drugs

Reps Introduce Bill to Lower Insulin Cost

Bipartisan House members introduce legislation they say will lower insulin costs.

Human Drugs

CDER Approves 48 Drugs in 2019; 20% Less Than 2018

CDER approves 48 new molecular entities in 2019, which is 20% below last years record 59 submissions.

Medical Devices

LivaNova Recalls VNS Generator System

LivaNova recalls (Class 1) its VNS Therapy SenTiva Generator System due to an unintended reset error that causes the system to stop delivering therapy...

Federal Register

Input Sought on FDA Minority Health Priorities

Federal Register notice: FDA seeks input and comments from interested stakeholders to help it establish strategic priorities for its Office of Minorit...

Human Drugs

Aurobindo Recalls Mirtazapine Over Label Error

Aurobindo Pharma recalls one lot of mirtazapine due to a label error on declared strength.

Medical Devices

Non-Clinical Bench Performance Guidance Out

FDA issues a guidance describing relevant information to be included in premarket submissions reporting non-clinical bench performance testing,

FDA General

FDA Vaping Enforcement Priorities Guidance

FDA publishes a guidance on its enforcement priorities for Electronic Nicotine Delivery System (vaping) products being marketed without FDA authorizat...

Medical Devices

Neovasc PMA Filed for Refractory Angina Device

Neovasc files a PMA for its Neovasc Reducer for treating refractory angina.