The FDA issued a proposed rule to clarify the cGMP requirements applicable to combination products in the Federal Register. The FDA issued a proposed rule to clarify the cGMP requirements applicable ...

New Delhi, Oct 10 (PTI) To provide faster disposal of merger and acquisition cases, the Competition Commission Wednesday amended the combination regulations with regard to withdrawal and refiling of ...

Navigating FDA's rules to get a fixed-dose combination therapy for chronic obstructive pulmonary disease approved required a large study and a specific population. When GlaxoSmithKline designed the ...

The regulation-by-enforcement critique has made an impact at the Securities and Exchange Commission, and scholars are beginning to turn this critique against other agencies. Using this critique, this ...

(HealthDay News) — General practitioners (GPs) can safely exclude pulmonary embolism using the Wells rule for pulmonary embolism in combination with either a qualitative point-of-care (POC) D-dimer ...

The US Food and Drug Administration issued a proposed rule to clarify the current good manufacturing practice (CGMP) requirements applicable to combination products in the Sept. 23 Federal Register.