Saturday, August 24, 2019

Saturday, August 24, 2019

Latest News

FDA approvals of new drugs, biological products dip slightly in FY2019

New drug and biological product approvals were down slightly in the first three quarters of the current fiscal year, compared to the same period in the previous year, according to data released by the U.S. Food and Drug Administration.

FDA Update: electronic submissions statistics

Electronic regulatory submissions sent to the U.S. Food and Drug Administration have increased year-by-year since the electronic system was launched in 2009, the FDA reports.

FDA Update: Mammography Procedure Numbers

Mammograms per year in the nation numbered more than 39.5 million as of Aug. 1, the U.S. Food and Drug Administration reports.

FDA issued 14 warning letters to companies in July

The U.S. Food and Drug Administration issued 14 warning letters in July that were sent to manufacturers and other companies found to have violated FDA regulations.

FDA issued 34 warning letters to companies in June

The U.S. Food and Drug Administration issued 34 warning letters in June that were sent to manufacturers and other companies found to have violated FDA regulations.

Annual volume of FDA-regulated imported goods up 5-10%

Products imported into the United States that require screening by the Food and Drug Administration continue to increase at a rate between 5 and 10 percent annually, the FDA reports.

FDA OK'd 227 drugs in June

The U.S. Food and Drug Administration approved 227 drug products in June, according to an online list the agency updated this week.

U.S., 27 EU nations join drug inspection accord

As of this month, 27 European nations are part of a mutual recognition agreement that allows regulatory agencies such as the U.S. Food and Drug Administration to rely on drug inspection data conducted within member nations.

FDA Update: Which drugs are in short supply?

The Food and Drug Administration this week updated its list of which drugs are in short supply in the nation and which previous drug shortages have been resolved.

Emerging biotech firms rival big pharma in new drug development, study finds

Emerging biotech companies developed nearly two-thirds of the new drug therapies approved last year in the United States, according to a new study by the pharmaceutical research company Iqvia.

FDA OK'd 481 drugs in May

The U.S. Food and Drug Administration approved 481 drug products in May, according to an online list the agency updated this week.

FDA Update: Which drugs are in short supply?

The Food and Drug Administration this week updated its list of which drugs are in short supply in the nation and which previous drug shortages have been resolved.

Cook, Los Angeles, Miami-Dade counties most at risk of measles outbreak, study finds

Illinois’ Cook County is the U.S. jurisdiction most at risk of a measles outbreak this year, according to a study published this month in the British medical journal The Lancet Infectious Diseases.

Measles cases in U.S. hit 839 so far this year, CDC reports

The number of U.S. measles cases confirmed this year reached 839 as of May 10, the highest level for any year since the nation declared the disease eliminated in 2000, according to the Centers for Disease Control and Prevention.

FDA OK'd 438 drugs in April

The U.S. Food and Drug Administration approved 438 drug products in April, according to an online list the agency updated this week.

FDA Update: Which drugs are in short supply?

The Food and Drug Administration this week updated its list of which drugs are in short supply in the nation and which previous drug shortages have been resolved.

Rising number of FDA advisory positions left unfilled

The number of vacancies on U.S. Food and Drug Administration advisory committees ticked upward during the final months of 2018, according to the agency’s most recent numbers.

Fiscal year 2019 FDA medical device fees released

Fee rates and payment instructions for companies submitting new medical device applications to the federal Food and Drug Administration have been released for fiscal year 2019, which began on Oct. 1, 2018.

Measles cases in U.S. hit 465 so far this year, CDC reports

The number of U.S. measles cases confirmed this year as of April 4 reached 465, the second-highest level for any year since the nation declared the disease eliminated in 2000, according to the Centers for Disease Control and Prevention.

FDA OK'd 272 drugs in March

The U.S. Food and Drug Administration approved 272 drug products in March, according to a list the agency published on Thursday.

FDA Reporter