Industry News

FDA Commissioner Scott Gottlieb issued a statement that FDA will be modernizing regulatory programs in order to advance novel treatments.

The Trump budget boosts funding for FDA but squeezes resources for NIH and healthcare.

FDA sent a warning letter to Celltrion detailing CGMP violations, including poor microbial contamination control.

A new report states that more research and clinical development must be done in the treatment of pain and addiction.

Gottlieb promoted the development of biosimilars and safer opioid packaging at a briefing sponsored by Alliance for a Stronger FDA and the Pew Charitable Trusts.

CPhI North America 2018, taking place Apr. 24-26 in Philadelphia, PA, has announced Dr. Bertalan Mesko as its first keynote speaker.

The agency met to discuss its new temporary and permanent premises in Amsterdam.

The guidance addresses the development, analysis, and presentation of microbiology data during antibacterial drug development.

New programs and initiatives by industry examine rising healthcare costs.

The NECC supervisory pharmacist at the center of the 2012 fungal meningitis outbreak was sentenced to 8 years in prison.

The President described US drug costs as unfair and stated that prices will come down.

Federal agencies have partnered to develop a roadmap that offers a new framework for the safety testing of drugs and chemicals without the use of animals.

A collaboration between The Centre for Process Innovation and The Roslin Institute aims to develop commercially viable and scalable methods of producing biologics using transgenic animals.

FDA Commissioner Scott Gottlieb says FDA is committed to meet the challenges faced by the saline shortage during an aggressive flu season.

FDA and industry weigh broader use of prior knowledge in biotechnology testing and production.

A manufacturing disruption has led to an EpiPen shortage in Canada, which currently has no alternative auto-injectors available on the market.

EMA will be using temporary premises in the city while construction of the new building takes place, which is not ideal because it requires moving the agency's headquarters twice.

The agencies sent warning letters to several companies that the agencies say are illegally marketing unapproved products to treat opioid addiction and withdrawal.

The latest continuing resolution funds the government for three weeks.

The funding from the Walloon Region will enable Univercells to start developing a manufacturing platform aimed at driving down costs of biosimilars manufacturing.

The FDA center released its list of planned guidance documents for the rest of the year.

The agency is sending a survey out to pharmaceutical companies in the UK to gain information on their preparedness for Brexit.

Non-essential activities and new regulatory submissions are on hold until a federal government funding agreement is reached.

Frustrated with chronic shortages and high costs, hospitals form their own generic drug company.

Researchers at Purdue University and and industry experts have partnered up at the Advanced Lyophilization Technology Hub to optimize the 70-year-old freeze-drying process.

The company has expanded its voluntary nationwide recall to include a second lot of Nexterone injection. This recall is due to particulate matter found in the product.

FDA is monitoring the IV fluid shortage occurring due to Hurricane Maria and is asking companies to submit data for the possibility of extending expiration dates.

The two agencies have launched a program to develop safe and effective medical products to be used by American military personnel.