September 28th 2023
The agency will be reorganizing field force and compliance functions.
August 1st 2023
Manufacturer lawsuits prompt CMS to [slightly] modify pricing plan.
July 1st 2023
Problems continue despite actions by regulators to better prevent and address drug shortages.
June 1st 2023
An increase in applications for gene therapies is putting stress on FDA’s resources.
May 1st 2023
FDA is encouraging sponsors to conduct studies and file applications for full approval of products authorized by Emergency Use Authorizations.
Regulatory Roundup
Updates on user fees, heparin supply concerns, orphan drug incentives, REMS updates, reference standards for proteins, and patent settlements.
EU Raises API Standards: A Curse in Disguise?
The aim of the European Falsified Medicines Directive is to improve the quality of imported APIs, but does the pain now outweigh the gain?
FDA Works to Secure Drug Supply Chain
New FDA supply chain policies aim to strengthen inspection and oversight processes.
Seeking Harmonization in Nanomedicines Regulatory Framework
Nanomedicines have been authorized by European licensing agencies for more than 30 years but are still posing regulatory difficulties.
Generic Drugs Face Regulatory and Scientific Challenges
FDA funds research to further development of innovative generics, while working to address review and approval issues.
FDA Urges Greater Focus on Contractor Quality
Increased manufacturer outsourcing requires clear policies and written agreements with CMOs.
Congress Considers Legislation to Secure Drug Supply Chain
Bills to regulate drug compounding and establish a national track and trace system face political and policy differences.
A Lifecycle Approach to Process Validation
A science- and risk-based approach to verify and demonstrate that a process operating within predefined specified parameters consistently produces material that meets all its critical quality attributes.
The Meaning of Metrics
Companies can use metrics as a tool to help drive positive change and quality process improvements.
Regulatory Convergence Sought for Global Pharma Market
Manufacturers work with international authorities to harmonize drug registration and supply-chain oversight.
Manufacturers Under Pressure to Manage Painkillers
Opioid abuse generates calls for efforts to curb distribution.
Vaccine Innovation Yields New Products and Processes
Vaccine development is benefiting from manufacturing advances.
GMP Compliance Becomes Prominent Enforcement Issue
Shortages spur efforts to overhaul manufacturing oversight.
Drug Quality at Center Stage for FDA and Manufacturers
Research Policies Pose New Challenge for US Administration
White House and Congress likely to struggle over funding for bio/pharmaceutical regulation.
Product Analysis Key to Biosimilar Development
Manufacturing and in-depth characterization provide basis for demonstrating product equivalence.
New Era for Generic Drugs
User fees aim to speed approvals and support inspections.
Campaign Mounts to Curb Counterfeit Drugs
Manufacturers and regulators struggle to control phony versions of crucial medicines.
