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opinion columns

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Use Quantitative Information for Consumer-Facing Promotion, FDA Guidance Says

Pharma Leaders

JUNE 27, 2023

Don’t waste your time on unending, unproductive online searches for news stories, reports and opinion; let DID’s experienced in-house editorial team do the work for you. Use your energy where it’s needed most — ensuring that your products are in compliance and getting to market as quickly as possible.

FDA

FDA Manufacturing Pharmaceutical Pharma

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FTC Slams District Court Decision, Supports Pharmacies in Bystolic Antitrust Case

Pharma Leaders

JUNE 22, 2023

Don’t waste your time on unending, unproductive online searches for news stories, reports and opinion; let DID’s experienced in-house editorial team do the work for you. Use your energy where it’s needed most — ensuring that your products are in compliance and getting to market as quickly as possible.

FDA

FDA Manufacturing Pharmaceutical Pharma

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Fierce Pharma

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CBER, CDER Directors Review Priorities and Challenges at FDLI Annual Conference

Pharma Leaders

MAY 19, 2023

Don’t waste your time on unending, unproductive online searches for news stories, reports and opinion; let DID’s experienced in-house editorial team do the work for you. Use your energy where it’s needed most — ensuring that your products are in compliance and getting to market as quickly as possible.

FDA

FDA Manufacturing Pharmaceutical Pharma

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Califf: Diabetes, Weight Loss, Alzheimer’s Drugs Could Be “Major Game Changers”

Pharma Leaders

MAY 17, 2023

Don’t waste your time on unending, unproductive online searches for news stories, reports and opinion; let DID’s experienced in-house editorial team do the work for you. Use your energy where it’s needed most — ensuring that your products are in compliance and getting to market as quickly as possible.

FDA

FDA Manufacturing Pharmaceutical Pharma

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FDA Seeks Feedback on AI and Machine Learning in Drug Development

Pharma Leaders

MAY 12, 2023

Don’t waste your time on unending, unproductive online searches for news stories, reports and opinion; let DID’s experienced in-house editorial team do the work for you. Use your energy where it’s needed most — ensuring that your products are in compliance and getting to market as quickly as possible.

FDA

FDA Manufacturing Pharmaceutical Pharma

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Senate HELP Committee Votes to Send Four Drug Reform Bills to Full Chamber

Pharma Leaders

MAY 11, 2023

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FDA

FDA Manufacturing Pharmaceutical Pharma

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FDA Final Guidance on Glycerin, High-Risk Drug Components Aims to Prevent Poisonings

Pharma Leaders

MAY 9, 2023

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FDA

FDA Manufacturing Pharmaceutical Pharma

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MDSAP QMS Implementation Plan Highlights Ongoing Assessments and Improvements

Pharma Leaders

MAY 8, 2023

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FDA

FDA Manufacturing Pharmaceutical Pharma

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FDA Final Guidance Details PDUFA VII Fee Program, Assessment Changes

Pharma Leaders

MAY 5, 2023

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FDA

FDA Manufacturing Pharmaceutical Pharma

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Number of Overdue Priority Review ANDAs Dips in FY 2023

Pharma Leaders

MAY 3, 2023

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FDA

FDA Manufacturing Pharmaceutical Pharma

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FDA Issues Final Guidance on Nicotine Replacement Therapies

Pharma Leaders

MAY 1, 2023

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FDA

FDA Manufacturing Pharmaceutical Pharma

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Maker of Generic Abortion Pill Sues FDA to Prevent Potential Enforcement Actions

Pharma Leaders

APRIL 20, 2023

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FDA

FDA Manufacturing Pharmaceutical Pharma

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Warning Letters Trend Toward Component Testing, Contractor Oversight in 2022

Pharma Leaders

APRIL 18, 2023

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FDA

FDA Manufacturing Pharmaceutical Pharma

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Interview: CDER OND Director Stein on Novel Drugs, Expedited Approval Pathways

Pharma Leaders

APRIL 14, 2023

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FDA

FDA Manufacturing Pharmaceutical Pharma

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CBER Director Highlights Hiring Challenges, Other Issues Ahead for Fiscal 2024

Pharma Leaders

APRIL 7, 2023

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FDA

FDA Manufacturing Pharmaceutical Pharma

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FDA Requires Opioids Producers to Supply Mail-Back Envelopes for Disposal

Pharma Leaders

APRIL 4, 2023

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FDA

FDA Manufacturing Pharmaceutical Pharma

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Jury Says Sandoz Owes $39M for Eyelash Drug Patent Infringement

Pharma Leaders

APRIL 3, 2023

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FDA

FDA Manufacturing Pharmaceutical Pharma

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Drug Supply Chain is Vulnerable to Threats, Says Senate Committee

Pharma Leaders

MARCH 27, 2023

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FDA

FDA Manufacturing Pharmaceutical Pharma

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Better Matching of Patients to Oncology Drugs is Goal of New FDA Pilot Project

Pharma Leaders

JUNE 20, 2023

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FDA

FDA Patients Manufacturing Pharmaceutical

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EU GMP Report — June 2023

Pharma Leaders

JUNE 15, 2023

Don’t waste your time on unending, unproductive online searches for news stories, reports and opinion; let DID’s experienced in-house editorial team do the work for you. Use your energy where it’s needed most — ensuring that your products are in compliance and getting to market as quickly as possible.

FDA

FDA Manufacturing Pharmaceutical Pharma

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FDA Calls on Xeris to Correct Misleading Safety and Efficacy Claims

Pharma Leaders

JUNE 14, 2023

Don’t waste your time on unending, unproductive online searches for news stories, reports and opinion; let DID’s experienced in-house editorial team do the work for you. Use your energy where it’s needed most — ensuring that your products are in compliance and getting to market as quickly as possible.

Safety

Safety FDA Manufacturing Pharmaceutical

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FDA Guidance Outlines GDUFA III Fee Program Changes

Pharma Leaders

JUNE 9, 2023

Don’t waste your time on unending, unproductive online searches for news stories, reports and opinion; let DID’s experienced in-house editorial team do the work for you. Use your energy where it’s needed most — ensuring that your products are in compliance and getting to market as quickly as possible.

FDA

FDA Manufacturing Pharmaceutical Pharma

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FDA Moves Ahead With PDUFA VII Commitments on Real-World Evidence

Pharma Leaders

JUNE 6, 2023

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FDA

FDA Manufacturing Pharmaceutical Pharma

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FDA Issues Development Program Guidances to Assist Drug, Device Sponsors

Pharma Leaders

JUNE 2, 2023

Don’t waste your time on unending, unproductive online searches for news stories, reports and opinion; let DID’s experienced in-house editorial team do the work for you. Use your energy where it’s needed most — ensuring that your products are in compliance and getting to market as quickly as possible.

FDA

FDA Manufacturing Pharmaceutical Pharma

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SCOTUS Sends False Claims Drug Pricing Case Back to Lower Court

Pharma Leaders

JUNE 1, 2023

Don’t waste your time on unending, unproductive online searches for news stories, reports and opinion; let DID’s experienced in-house editorial team do the work for you. Use your energy where it’s needed most — ensuring that your products are in compliance and getting to market as quickly as possible.

FDA

FDA Manufacturing Pharmaceutical Pharma

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Adverse Events Show Slight Rise in FDA Surveillance & Epidemiology Annual Report

Pharma Leaders

MAY 31, 2023

Don’t waste your time on unending, unproductive online searches for news stories, reports and opinion; let DID’s experienced in-house editorial team do the work for you. Use your energy where it’s needed most — ensuring that your products are in compliance and getting to market as quickly as possible.

FDA

FDA Manufacturing Pharmaceutical Pharma

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FDA Guidance Roundup

Pharma Leaders

MAY 25, 2023

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FDA

FDA Manufacturing Pharmaceutical Pharma

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Breast Imaging Sales With Shirley Taylor Part 2

Evolve Your Success

DECEMBER 13, 2022

Find out, when you talk to someone else, what they’re doing in a space that you might be interested in the medical space, compare it and say, “Do I have the skills for my list and column that could go over to that? What do I need to get there?”. What about those current sales reps now? Shirley also believes in community engagement.

Sales

Sales Medical sales Medical Medical sales reps

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FDA Proposes Rule to Replace Medication Guides With Single-Page Info Sheets

Pharma Leaders

MAY 30, 2023

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FDA

FDA Medical Manufacturing Pharmaceutical

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Republican Lawmakers Press Califf for Answers About Ongoing Drug Shortages

Pharma Leaders

MARCH 31, 2023

Don’t waste your time on unending, unproductive online searches for news stories, reports and opinion; let DID’s experienced in-house editorial team do the work for you. Use your energy where it’s needed most — ensuring that your products are in compliance and getting to market as quickly as possible.

FDA

FDA Manufacturing Pharmaceutical Pharma