Melissa Gilmore

Melissa Gilmore

Polsinelli

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FDA Targets Medical Device Companies

FDA Developing New Risk and Benefit Perception Scale - Since 2008, the U.S. Food and Drug Administration has increased its presence and tightened its control over medical device companies, and this trend is expected to...more

5/19/2014 - Biotechnology Enforcement Enforcement Actions FDA Healthcare Medical Devices

Changes Coming To Prescription Drug Advertising

FDA Developing New Risk and Benefit Perception Scale - On April 21, 2014, continuing its scrutiny of the disclosures of risks and benefits in prescription drug advertising, FDA announced a plan to conduct a study...more

5/6/2014 - Advertising FDA Prescription Drugs

FDA Issuing Referral Letters To State Boards Of Pharmacy Against Traditional Pharmacies

FDA has recently issued several "referral letters" (RLs) to state boards of pharmacy based on year-old pre-Compounding Quality Act Form 483 Inspectional Observations. FDA counts RLs as new instruments of oversight designed to...more

3/19/2014 - FDA Pharmaceutical Pharmacies

Breaking News: FDA Testifies Before Senate HELP Committee, Questioned On Recent Compounding Quality Act Enforcement

Today Senator Lamar Alexander (R-TN), member of the Senate HELP Committee asked FDA Commissioner Margaret Hamburg what FDA's policy was with regard to asserting jurisdiction over 503A traditional compounding pharmacies. He...more

3/14/2014 - Drug Compounding FDA Pharmaceutical Pharmacies

FDA Issues First Compounding Pharmacy Warning Letter Under DQSA/503B

On January 17, FDA issued its opening sally in the new compounding pharmacy enforcement regime by issuing a Warning Letter to Avella of Deer Valley in Phoenix, AZ. The letter is based on a nearly year-old inspection (February...more

2/4/2014 - DQSA Drug Compounding FDA Misbranding Pharmaceutical Pharmacies Prescription Drugs

Draft Guidance: Pharmacy Compounding Of Human Drug Products Under Section 503A Of The Federal Food, Drug, And Cosmetic Act

Following enactment of the Drug Quality and Security Act last month, FDA has quickly issued a new guidance for compounding pharmacies that choose to not register as "outsourcing facilities" and subject themselves to federal...more

12/18/2013 - Drug Compounding FDA Pharmaceutical Pharmacies Prescription Drugs

FDA Deputy Commissioner Details Agency’s Priorities In Recent Speech

In This Issue: - Snapshot of the Agency: FDA-regulated products - Recent Public Health Milestones - Innovative Programs at FDA ..A. FDA has a number of programs intended to speed the availability of...more

12/17/2013 - Affordable Care Act Approval Clinical Trials FDA Food Safety Generic Drugs Healthcare Healthcare Reform Medical Devices New Regulations Prescription Drugs Proposed Regulation Veterinary Products

Compounding Quality Act: Critical Implementation Begins Now For Stakeholders

On Wednesday, December 4, FDA will publish six key documents in the implementation of the Compounding Quality Act, signed into law by President Obama on Monday, December 2. In addition, FDA has withdrawn its current guidance...more

12/5/2013 - Drug Compounding Drug Manufacturers FDA Pharmacies Prescription Drugs Shareholders

Key Points: Compounding Quality Act

The Compounding Quality Act (CQA) amends the U.S. Food, Drug & Cosmetic Act (Act) to create a new, voluntary category of compounders called "outsourcing facilities" (OF). Compounded drugs are those mixed by a pharmacist that...more

11/29/2013 - Drug Compounding FDA FDCA Pharmacies Registration

Congress Passes Compounding Quality Act

The Senate approved a human prescription compounding bill (H.R. 3204) Monday by voice vote, sending it to President Obama for his signature. The bill had been in the works since last year, when a meningitis outbreak from...more

11/22/2013 - Drug Compounding FDA FDCA Fungal Meningitis New Legislation Pharmacies Safety Inspections Safety Precautions

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