Typically, FDA inspections can be highly structured and there are procedures that are to be followed as you prepare for state of readiness. It is important for anyone who might be involved in the ...

IMPACT OF STAFF CUTS — Job cuts at the FDA could threaten the yearslong effort to return the agency’s inspections of foreign manufacturing plants to pre-pandemic levels. While the Trump ...

(MENAFN- GlobeNewsWire - Nasdaq) Join the FDA Inspection Preparedness & Compliance online Training (May 7-8, 2025) to master regulatory inspection readiness for pharma, biotech, biologics ...

in order to continue and maintain FDA's regulatory inspection presence and the gold standard of excellence," agency officials wrote, in emails and draft contracting documents obtained by CBS News.

When FDA inspectors went to the Glenmark plant last month — five years after the agency’s prior inspection — they discovered problems with cleaning and testing that they said could affect ...

The Food and Drug Administration (FDA) has approved a new drug for treating urinary tract infections (UTIs), the first such drug approved in decades and the first in a new class of medications.

According to GSK, the last time the FDA cleared a new class of antibiotics for uncomplicated UTIs was in 1996, with the approval of fosfomycin. (Last year, the agency approved the drug Pivya for ...

The Senate on Tuesday night confirmed Marty Makary to be commissioner of the Food and Drug Administration (FDA). Makary was confirmed by a 56-44 vote, picking up three Democrats. Democratic Sens.

When FDA inspectors went to the Glenmark plant last month — five years after the agency’s prior inspection — they discovered problems with cleaning and testing that they said could affect medicines ...

Notable expressions included "high confidence" in facility readiness and "strong statistical significance" of trial data. The current quarter emphasized the FDA BLA acceptance for priority review ...