Keyword: Food and Drug Administration (FDA)
News
07.03.2017
- Regulators in the EU and the US have signed a transatlantic agreement to recognize inspections of manufacturing sites for human medicines carried out in their respective countries...
News
27.02.2017
- The US Food and Drug Administration (FDA) has accepted Swiss pharmaceutical major Novartis’ supplemental New Drug Application (sNDA) for filing and granted priority review for the...
News
07.02.2017
- US drugmaker Mylan is facing a probe from the Federal Trade Commission (FTC) as to whether it has violated antitrust laws in protecting its EpiPen from lower-priced competitors...
News
01.02.2017
- In a meeting at the White House on Jan. 31, new US president, Donald Trump, held out both a carrot and a stick to pharmaceutical producers. The industry will “have to “get prices...
News
05.01.2017
- The US state of Texas has filed a lawsuit against the Food and Drug Administration in the federal district court of Galveston, seeking to force the regulatory agency to agree to...
News
29.11.2016
- The US House of Representatives has scheduled a Nov. 30 vote on a bill aimed at accelerating federal approval of drugs and medical devices as well as boosting biomedical research...
News
14.11.2016
- Based on positions he took during the election campaign, the US pharmaceutical and biotech sectors stand to benefit from a Donald Trump presidency, some analysts have suggested. In...
News
11.10.2016
- The European Parliament’s (EP) recently revised rules to prevent trade in goods and services that may contribute to torture or execution could potentially have further knock-on...
