The FDA may mention a specific date or a period (say Q1, Q2, Q3, Q4, first-half, second-half, the name of the month) as the timeline by which a decision will be given. If the FDA does not mention ...

There were unforgiveable shortcomings in management, which included critical information not reaching senior officials as ...

Lab-developed tests (LDTs) are laboratory tests where blood is drawn and placed in a test tube to help with identification, diagnosis, and ...

In the wake of the 2024 U.S. elections, stakeholders in the life sciences and health care industry are intensely focused on the policy ...

Cipla on Monday (January 20) announced that the United States Food and Drug Administration conducted an inspection of its ...

In response to a report from the Government Accountability Office, the FDA says the biggest stumbling block to conducting inspections of food facilities ...

Cipla share price has risen by 10% over the past 12 months and 64% over the last three years. The company's current market ...

Laurus Labs' U.S. subsidiary receives Form 483 from FDA after PADE inspection, to address observation promptly.

WASHINGTON — The Food and Drug Administration (FDA) has fallen short of its facility inspection targets, according to the Food Safety: FDA Should Strengthen Inspection Efforts to Protect the US Food ...