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EU MDR Compliance: A Checklist for Meeting Manufacturing, Safety and Performance Requirements

The FDAnews report EU MDR Compliance can help. Our editors have combed through the regulations, picking out the most minute compliance points and building them into a checklist of 200+ requirements you can use to confirm that you are satisfying all the EU mandates for device manufacturing.

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Accelerating Generic Drug Development: The FDA’s New Plan for Increasing Generic Competition

Accelerating Generic Drug Development explains the FDA’s new policy and shows how to navigate the new pathway to approval.

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Regulatory Affairs
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Drugmakers Seek Clarity on FDA’s Plan for Real-World Evidence in Trials

February 13, 2019

Drug sponsors are eager for the FDA to embrace real-world evidence, but several companies are asking the agency to clarify how it can be used in clinical trials. Read More

Lawmakers Press FDA for Documents Relating to Controversial Opioid Approval

February 13, 2019

Congressional Democrats are calling on the FDA to answer “substantive questions” surrounding the agency’s approval of Dsuvia, AcelRx’s sublingual formulation of the powerful opioid sufentanil. Read More

FDA Lays Out Final Guidance for Buprenorphine Pumps, Injections

February 13, 2019

The agency approved the first combination buprenorphine injection product two years ago. Read More

FDA Unveils New Supply Chain Pilot Program

February 13, 2019

The agency wants to find out the best way to “operationalize” supply chain security. Read More

Compounder Hit With Consent Decree Over Insanitary Production Conditions

February 13, 2019

The decree restricts the compounder from manufacturing, holding or distributing sterile drugs compounded at the facility. Read More

FDA Issues Manual on Developing a Shared System REMS

February 13, 2019

The agency will issue a letter to ANDA applicants informing them of the requirement to establish a shared REMS with the sponsor of the referenced NDA. Read More

Ways & Means Takes Testimony on Lowering Drug Prices

February 12, 2019

House Democrats on Tuesday opened their own bid to reform the nation’s prescription drug prices. Read More

EU Considers Harmonized Drug Shortage Definition

February 12, 2019

The lack of a standard definition for drug shortages in the EU is preventing regulators from developing an EU-wide strategy for handling shortages, according to the European Medicines Agency. Read More

FDA Names New Director for the Office of Generic Drugs

February 12, 2019

CDER Director Janet Woodcock announced on Tuesday that Sally Chloe will be the new director of the Office of Generic Drugs at the end of the month. Read More

Joint Advisory Committee Backs Janssen’s NDA for Treatment-Resistant Depression

February 12, 2019

A joint FDA advisory committee voted in favor of the safety, efficacy and risk-benefit profile of Janssen’s NDA for treatment of treatment-resistant depression. Read More

ICH Considers Harmonizing Generics Standards Across Borders

February 12, 2019

The paper also suggests guidelines on bioequivalence standards for products with complex formulations. Read More

FDA Issues Recommendations for Esophagitis Drug Trials

February 12, 2019

The agency said Phase 3 trials should evaluate the drug’s effect on both symptoms and the underlying inflammation of the disease. Read More

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EU MDR Compliance: A Checklist for Meeting Manufacturing, Safety and Performance Requirements

Accelerating Generic Drug Development: The FDA’s New Plan for Increasing Generic Competition

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Regulatory Affairs
RSS

Drugmakers Seek Clarity on FDA’s Plan for Real-World Evidence in Trials

Lawmakers Press FDA for Documents Relating to Controversial Opioid Approval

FDA Lays Out Final Guidance for Buprenorphine Pumps, Injections

FDA Unveils New Supply Chain Pilot Program

Compounder Hit With Consent Decree Over Insanitary Production Conditions

FDA Issues Manual on Developing a Shared System REMS

Ways & Means Takes Testimony on Lowering Drug Prices

EU Considers Harmonized Drug Shortage Definition

FDA Names New Director for the Office of Generic Drugs

Joint Advisory Committee Backs Janssen’s NDA for Treatment-Resistant Depression

ICH Considers Harmonizing Generics Standards Across Borders

FDA Issues Recommendations for Esophagitis Drug Trials

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Regulatory Affairs
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