FDA Drops Proposal Requiring Sponsors to Report Falsified Data
The FDA scrapped a proposed rule that would have required drug sponsors to report possibly fabricated data in the clinical trials. Source: International Pharmaceutical Regulatory Monitor
CHMP Recommends Six Medicines for Approval
The EMA’s Committee for Medicinal Products for Human Use recommended six medicines for approval at its October meeting. Source: International Pharmaceutical Regulatory Monitor
483 Roundup: FDA Calls Out Four Firms Over Testing, Sanitation
The FDA issued 483s to five drug manufacturers, taking them to task for quality issues that included sanitation and testing practices. Source: Drug GMP Report
Hatch, Bennet Introduce Bill to Update Labeling Standards
Sens. Orrin Hatch (R-Utah) and Michael Bennet (D-Colo.) announced a bill that would update what they say are outdated drug labeling standards. Source: Drug GMP Report
FDA and EMA Take Action Against Zhejiang Huahai Over GMP Violations
The FDA placed valsartan manufacturer Zhejiang Huahai on an import alert and the EMA issued a noncompliance statement barring Europe’s drugmakers from using the company’s API in their blood pressure…
EMA Enters New Phase of Brexit Preparations
The European Medicines Agency entered the third phase of its plan to keep industry gears moving while the agency prepares for the UK’s exit from the EU, and said it…
OTC Drugmaker in Tennessee Hit with Consent Decree
Keystone Laboratories of Memphis, Tennessee, was hit with a consent decree ordering the company to stop selling over-the-counter drugs until it complies with current manufacturing practice requirements. Source: Drug GMP…
FDA Guidance Explains Verification Systems for Certain Drugs
The FDA issued draft guidance that outlines what the agency considers an ideal and robust verification system that’s also in line with legislative requirements. Source: Drug GMP Report
Warning Letter Roundup: Facilities Slammed for CGMP Violations
The FDA issued warning letters to four drugmakers over various CGMP violations at their facilities, some of which created risks of product contamination. Source: Drug GMP Report
FDA Releases List of Upcoming Rulemakings
The FDA released its latest semi-annual regulatory agenda listing the agency’s planned rulemakings for pharmaceuticals, including: Source: Drug GMP Report
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