Remove 2010 Remove FDA Remove Pharmaceutical Companies
article thumbnail

Rare Disease Spotlight – tracing the rise of orphan drug designations over almost 40 years

Pharmaceutical Technology

The US Food and Drug Administration (FDA) put a high-profile bluebird bio trial for sickle cell disease on partial clinical hold, and advisory panels deliberated over decisions involving gene therapies for amyotrophic lateral sclerosis (ALS), cerebral adrenoleukodystrophy (CALD), and beta-thalassemia.

article thumbnail

Botanical drugs – what is the best way forward for regulatory and market approval?

European Pharmaceutical Review

In the US, botanical dietary supplements can be sold without US Food and Drug Administration (FDA) approval, 1 prompting many vendors to promote the use of botanical products as dietary supplements , 2 rather than pursue a path of regulatory approval. 3 Is two too few? 3 Is two too few?

FDA 103
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

An Annex 1 and Pharma 4.0 perspective on water quality

European Pharmaceutical Review

The US Food and Drug Administration (FDA) defines eight different types of water: non-potable, potable (drinkable), purified, water for injection (WFI), sterile water for injection, sterile water for inhalation, bacteriostatic water for injection and sterile water for irrigation. John Wiley & Sons, Ltd, 2010. Online] 13.

article thumbnail

Fixed-dose combination: Considerations for design, formulation, manufacturing and analysis

Pharmaceutical Technology

Pharmaceutical companies – and the FDA – are embracing FDCs. From 1990 through 2013, the FDA approved 131 FDC products, on average 5.7 From 1990 through 2013, the FDA approved 131 FDC products, on average 5.7 More FDC products flowing into pharma pipelines. The numbers tell the story. new FDC products per year.

article thumbnail

Are microtaggants the key to making medicines smarter?

pharmaphorum

Pharmaceutical companies are accountable for ensuring that their medicine is safe when it comes into the hands of patients. The FDA has stated that when microtaggants are pharmaceutically inactive and incorporated into new or existing drugs, they can be treated as excipients without the need for further clinical trials.

article thumbnail

Flomax generic availability, cost, and dosage

The Checkup by Singlecare

With its FDA approval in 1997, Flomax has become a widely prescribed medication in the United States, particularly for older men more susceptible to BPH. It is called tamsulosin and has been approved for use in the United States since 2010 when the brand name’s original patent expired. What are the off-label uses for Flomax?

Dosage 52
article thumbnail

Why Are FDA Inspections So Ineffective and Disappointing?

The People's Pharmacy

Why, then, are FDA inspections abroad so infrequent and disappointing? FDA Inspections Suspended: During the COVID pandemic, the Food and Drug Administration suspended its inspections at most foreign pharmaceutical facilities. Even under the best of conditions, the FDA never inspects all foreign pharmaceutical plants annually.

FDA 72