The U.S. Food and Drug Administration has published more than 200 complete response letters, or decision letters, sent as ...

The letters, many of which were already available online, detail why the regulators initially declined to approve some drugs.

Enhance FDA compliance with our expanded training on inspection processes, common issues, and strategies for prevention. Gain insights into Form 483 and warning letter prevention, root cause analysis, ...

Pune: Emcure Pharma has announced that the United States Food and Drug Administration (USFDA) has concluded a Pre-Approval ...

The FARAPULSE PFA System now approved for pulmonary vein and posterior wall ablation in patients with persistent atrial ...

The Inter-Ministerial Group is expected to examine the share purchase agreement (SPA) for IDBI Bank, after which it will be ...

Shares of firms like TCS, Akzo Nobel, Emcure Pharma, Adani Ent, Tata Technologies, and others will be in focus on Thursday's ...

The US FDA had conducted Pre-Approval Inspection of Emcure Pharmaceuticals Limited's manufacturing facility (Oncology) located at G.I.D.C., Taluka - Sanand, Ahmedabad - 382110, Gujarat, from June 30, ...

For a pharmaceutical company, a clean FDA inspection report is crucial for maintaining and expanding its presence in global markets ...

In April this year, the United States Food and Drug Administration (US FDA) had conducted a current Good Manufacturing ...

Granules India's subsidiary resolves FDA observation during inspection at Virginia facility, parent company confirms in filing.

The USFDA conducted an inspection at Unichem Laboratories Ltd's Roha API facility from 16th June 2025 to 20th June 2025 and issued a Form 483 with 3 observations.