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Home » Topics » Pharmaceuticals » Regulatory Affairs

Regulatory Affairs
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Gottlieb Sworn In as FDA Commissioner

May 11, 2017
Scott Gottlieb was sworn in as FDA commissioner May 11 and has his first full day on the job today. Read More

Senate Committee Advances FDA User Fee Reauthorization

May 11, 2017
The Senate HELP Committee on Thursday advanced to the full Senate a bill that would reauthorize FDA user fees through 2022. The vote was 21-2. Read More
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Congress Clears, President Signs Fiscal 2017 Spending Bill

May 11, 2017
Congress will also permit the agency to collect $1.23 billion in user fees for fiscal 2017. Read More

Senate Bill Would Speed Clinical Trials Process

May 11, 2017
A bipartisan bill introduced in the Senate would streamline the clinical trials process and expand patient access to experimental treatments. Read More

Clinical Trial Questions: FDA’s Answers

May 11, 2017
The FDA provides all the GCP regulations and guidances you need to run a clinical trial, but those documents can’t answer every question you may have. Fortunately, the agency offers another resource — the staff of its Office of Good Clinical Practices. Every day, OGCP fields questions from investigators, sponsors, IRBs and other interested parties. Read More

EMA Revises Guidance on Clinical Data Publication Policy

May 11, 2017
The European Medicines Agency has expanded the types of documents it will publish alongside clinical study reports from sponsors’ drug product applications. Read More

Gottlieb Confirmed as FDA Commissioner

May 11, 2017
The Senate confirmed Scott Gottlieb as the new FDA commissioner May 9 in a 57 to 42 vote. Read More

EMA Publishes Draft Guideline on Complying With Clinical Trial Master File Requirements

May 11, 2017
Trial master files should contain all documents necessary to adequately reconstruct the conduct of a clinical study, along with any decisions made and their justifications, according to European regulations. Read More

TGA Seeks Broader Authority to Penalize False Drug Advertising

May 10, 2017
Australia’s Therapeutic Goods Administration is proposing to expand its authority to impose sanctions and penalties for non-compliant ads. Read More

EMA Annual Report Lists 27 New Active Substances, Highlights PRIME Pathway

May 10, 2017
The European Medicines Agency published its annual report, listing 81 medicines recommended for approval in 2016, including 27 new active substances. Read More

Senate Committee Pushes Back User Fee Markup

May 10, 2017
Scheduling conflicts unrelated to the must-pass FDA user fee reauthorization bill postponed a planned markup Wednesday, but the Senate HELP committee has rescheduled the session for today. Read More

FDA Import Alert Leaves WHO with No Source for Birth Control API

May 10, 2017
Following the FDA’s addition of a Chinese API manufacturer to an import alert early last month, the World Health Organization was left without a prequalified source for the birth control drug levonorgestrel, also known as Plan B. Read More
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