Saturday, December 7, 2019

Saturday, December 7, 2019

Latest News

FDA issued 13 warning letters in October

The U.S. Food and Drug Administration (FDA) issued 13 warning letters in October that were sent to manufacturers and other companies found to have violated FDA regulations.

FDA Update: 2019 animal product recalls

The U.S. Food and Drug Administration recalled 28 animal products from January through September of 2019, the agency reported.

FDA Update: recent animal drug approvals

Federal law dictates that drug companies can’t manufacture and market medicines for animals unless they get the approval of the U.S. Food and Drug Administration.

FDA issued 19 warning letters to companies in September

The U.S. Food and Drug Administration issued 19 warning letters in September that were sent to manufacturers and other companies found to have violated FDA regulations.

FDA Update: international cooperative arrangements

Since the year 2000, the U.S. Food and Drug Administration has entered into 40 cooperative arrangements involving foods, pharmaceuticals or medical devices with foreign governments or partners in other nations, according to the FDA.

FDA Update: Import refusals in August

The U.S. Food and Drug Administration barred 485 shipments from entering the United States in August, according to FDA import records.

FDA held 10 drug application meetings in first 9 months of FY 2019

The U.S. Food and Drug Administration held 10 public meetings related to the review of license applications for drugs and biologics during the first three quarters of fiscal-year 2019, the regulatory agency reported last month.

Applications for new drugs, biological products dip slightly in FY2019

New drug and biological product application filings 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 issued 18 warning letters to companies in August

The U.S. Food and Drug Administration issued 18 warning letters in August that were sent to manufacturers and other companies found to have violated FDA regulations.

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 Reporter