Latest News | 3 January 2014

Technology Blueprints for PDUFA, GDUFA Programs Released for Comment

US regulators last week released the texts of two reports, mandated under the terms of the most recent user fee agreements, detailing two five-year plans to improve the information technology services Read More...

Latest News | 2 December 2013

Legislators to OMB: Sequestration of FDA User Fees Wrong, Should be Reversed

Legislators in the House of Representatives seem to have a consistent message for the White House's Office of Management and Budget (OMB), the office which effectively sets and enforces policy within Read More...

Latest News | 8 October 2013

PhRMA: 'Butterfly Effect' of Poor Legislative Policy Affecting Regulations, Patients

The US Pharmaceutical industry's standard-bearer, the Pharmaceutical Research and Manufacturers of America (PhRMA), is publicly expressing deep concern about the "significant impact" of budget cuts Read More...

Latest News | 4 September 2013

Priority Review Voucher Fees Set to Plummet for Second Consecutive Year

The US Food and Drug Administration (FDA) is relatively unique among federal agencies in that it draws much of its operating budget directly from the industries it regulates, including the Read More...

Latest News | 15 August 2013

FDA Gets Approval to Conduct Exit Interviews of Sponsors of NMEs, Original BLAs to Assess Performance

The Office of Information and Regulatory Affairs (OIRA), the US government regulator of regulations, has announced its approval of a new report set to be published in two years by the US Food and Drug Read More...

Latest News | 15 August 2013

Pharmaceutical Industry Experts Slam FDA's PDUFA Report, Calling it too Vague to be Useful

The pharmaceutical and biopharmaceutical industries have long been supportive of the user fee schemes used to fund the US Food and Drug Administration (FDA). Originally passed under the Prescription Read More...

Latest News | 1 August 2013

FDA Publishes All User Fee Rates for Fiscal Year 2014

The US Food and Drug Administration (FDA) has just published the user fee rates set to go into effect for the coming 2014 fiscal year (FY), including those for pharmaceuticals, biosimilars, Read More...

Latest News | 10 July 2013

As FDASIA Celebrates First Year, FDA Says Drugs, Devices Already Seeing Benefit

On 9 July 2012, US President Barack Obama quietly signed into law a piece of legislation that had received overwhelming support in both chambers of Congress – a relative rarity in the hyper-political Read More...

Latest News | 25 June 2013

BIO, PhRMA Announce Plan to Keep Tabs on PDUFA Progress Through Tracking Database

The Prescription Drug User Fee Act (PDUFA) is one of the single most important pieces of legislation affecting the life sciences industry, and in particular innovative pharmaceutical and Read More...

Under RAPS | 2 April 2013

Mastering the eCTD Format Critical for Regulatory Submissions Pros

The electronic Common Technical Document (eCTD) provides a common global standard for companies to electronically submit the quality, safety and efficacy information required by regulatory agencies. It is an EMA requirement and will soon be required by FDA, so anyone working on drug regulatory submissions needs to understand the format well. Read More...

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RF Today is Regulatory Focus' daily news brief. Each edition contains the top global regulatory news stories about pharmaceuticals, medical devices, biotechnology and more. Learn more

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