News & Analysis as of

Medical Devices Drug Pricing Manufacturers

Gardner Law

The Value of MDUFA

Gardner Law on

Anyone who has submitted a medical device for pre-market review knows the financial investment it takes to for FDA to conduct its review. Under the Medical Device User Fee Amendments (MDUFA), certain submissions, including...more

Quarles & Brady LLP

340B Developments in 2024 – Litigation and Legislation

Quarles & Brady LLP on

Although we are only two and a half months in, 2024 has already seen its fair share of impactful 340B developments on both the litigation and legislative fronts....more

BakerHostetler

FDA and Pharmacy Weekly Digest - September 2019 #4

BakerHostetler on

Food/Dietary Supplements - FDA to Hold Public Meeting on Food Standards of Identity – The FDA will hold a public meeting “to give interested persons an opportunity to discuss FDA’s effort to modernize food standards of...more

Hogan Lovells

The South African pharmaceutical regulatory environment

Hogan Lovells on

Our local pharmaceutical environment is highly regulated.The most important legislative provisions are found in the Medicines Act and the Pharmacy Act....more

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