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Latest News | 21 May 2012

PhRMA: Pre-Submission Advertising Guidance Violates Free Speech Rights

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The Pharmaceutical Research and Manufacturers of America (PhRMA) is calling for program proposed by the US Food and Drug Administration (FDA) to be scaled back, saying the agency’s proposal to review [Read More...]

Tags: Advertising Draft Guidance DTC FDA First Amendment Free Speech Guidance Narrowly Tailored PhRMA
Latest News | 16 May 2012

Biotechnology Companies Seek Changes, Clarification in Biosimilar Draft Guidance

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The US Food and Drug Administration’s (FDA) draft guidance on biosimilars attracted general praise and some pointed criticism at a public meeting held 11 May as companies jockeyed for more flexibility [Read More...]

Tags: Biogenerics Biologics Biosimilar Biosimilars Comments Draft Guidance FDA Follow-on Biologics Meeting
Latest News | 9 May 2012

FDA Issues New Draft Guidance on Pediatric X-Ray Imaging

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The US Food and Drug Administration (FDA) announced it is releasing new draft guidance for industry on what information needs to be contained with a company’s premarket notification for any x-ray [Read More...]

Tags: CDRH Draft Guidance FDA Medical Device Meeting Pediatric Warning X-Ray
Latest News | 26 April 2012

Biosimilars Guidelines Attract Attention, Criticism

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As Genetic Engineering & Biotechnology News reported in mid-April, the US Food and Drug Administration’s (FDA) draft biosimilar regulations attracted mostly negative comments. Now some companies are [Read More...]

Tags: Amgen BIO Biosimilar Biosimilars BPCI Comments Draft Guidance FDA Guidance Testing
Latest News | 16 April 2012

Report: Comments on Draft Biosimilar Guidelines Mostly Trend Negative

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Comments on the US Food and Drug Administration’s (FDA) February 2012 draft guidance documents on biosimilar are mostly negative and reflecting discontent with the required studies to prove [Read More...]

Tags: Biosimilar Biosimilars BPCI Comments Draft Guidance FDA Genentech Guidance Novo Nordisk Testing
Latest News | 12 April 2012

FDA Guidance on Veterinary Antibiotic Use Prompts Compliance, Criticism

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Shortly after the US Food and Drug Administration (FDA) released new rules to curtail the “injudicious” use of antibiotics in food-producing animals, three pharmaceutical manufacturers said they were [Read More...]

Tags: antibiotics CVM Draft Guidance Eli Lilly FDA Guidance Merck NRDC Pfizer Taylor Veterinary
Latest News | 10 April 2012

ICH Safety Reporting Standard Advanced by FDA

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A month after the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) released new standards on periodic benefit-risk evaluation [Read More...]

Tags: Draft Guidance drug E2C E2C (R2) FDA Guidance ICH PBRER Periodic benefit-rick evaluation reports Pharmaceutical
Latest News | 21 March 2012

FDA Releases Additional Draft Guidance on Product-Specific Bioequivalence Recommendations

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The US Food and Drug Administration (FDA) released additional draft guidance for industry on 21 March entitled Product-specific Bioequivalence Recommendations. The guidance covers 31 new drugs and [Read More...]

Tags: Bioequivalence CDER Draft Guidance drug FDA Pharmaceutical Product-Specific
Latest News | 16 March 2012

FDA Proposes Lowering Risk Classification for Devices Used to Detect Tuberculosis

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The US Food and Drug Administration (FDA) is calling for the reclassification of devices used to detect cases of tuberculosis (TB), lowering the current risk classification in a move that it hopes [Read More...]

Tags: Class II Class III Classification Draft Guidance FDA Risk TB Tuberculosis
Latest News | 8 March 2012

FDA Releases New Framework for Classifying Postmarket Drug Safety Issues

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The US Food and Drug Administration released new draft guidance on 8 March on classifying significant postmarket drug safety issues.The classification system—a three-tier approach in which postmarket [Read More...]

Tags: CDER Draft Guidance drug FDA Pharmaceutical Postmarket Safety Safety First Initiative Tracked Safety Issues
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