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Home » Topics » Pharmaceuticals » Regulatory Affairs

Regulatory Affairs
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One In, Two Out Executive Order Will Likely Increase Use of Internal FDA Communications

June 15, 2017
Much of the agency’s policymaking is done through clarification rather than new regulations. Read More
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FDA Rejects Coherus’ Neulasta Biosimilar, Calls for New Sample Analyses

June 15, 2017
The agency did not call for a clinical trial or for further process qualification lots. Read More

Pharma Groups Offer Fixes to FDA’s Outsourcing Regulations

June 14, 2017
PhRMA, BIO and The Pew Charitable Trusts have banded together to ask Congress to include language in the fiscal 2018 appropriations bills to clarify the FDA’s power to regulate compounding pharmacies. Read More

FDA Publishes Case Studies on Biomarker Qualification

June 14, 2017
The FDA highlighted two fictional case studies it published on the role biomarker qualification plays in drug development — as part of a reorganization of the agency’s biomarker materials — to help drugmakers understand the validation studies necessary to support qualification, the collaborative efforts involved and the potential benefits. Read More

TGA Plans to Allow Automatic, Instant Approvals of Lowest-Risk Product Variations

June 14, 2017
The industry requests will be characterized as notifications. Read More

Cures Act Left Drug-Device Distinction Murky, Panel Says

June 14, 2017
The law should have established a clear definition of where drugs begin and devices end. Read More

FDA Seeks Feedback on Proposed Disclosure Studies, Color Additive Rules

June 13, 2017
The FDA is seeking comment on a proposal to study how advertising disclosure statements and drug promotion affect consumers. Read More

FDA Planning Phased Transition to New Cures Act Drug Development Tool Qualification Scheme

June 13, 2017
The tool qualification process includes three requirements from the sponsor. Read More
Red and Grey Pills

FDA Requests Endo Remove Opioid Painkiller Opana ER from the Market After Reports of Abuse

June 13, 2017
Diluting the drug with extra water leads abusers to rely on more frequent injections. Read More

EMA to Continue Patient Engagement Efforts in Assessments

June 13, 2017
The EMA says it will continue to invite patients to in-person discussions between reviewers and product sponsors — following a successful two-year pilot project involving five medicines. Read More

EMA Issues Guideline for Reporting Clinical Trial Protocol Breaches

June 13, 2017
The European Medicines Agency has issued a new draft guideline on reporting breaches of clinical trial protocols. Read More

EMA Accepts Five Drugs for Priority Medicine Program

June 13, 2017
The European Medicines Agency named five treatments as eligible for its priority medicines program, bringing the total to 25. Read More
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