Food And Drug Administration | The Truth About Skin Care

{ Tag Archives } Food And Drug Administration

Sizing Up Nanotechnology: How Nanosized Particles May Affect Skin Care Products

The rapidly growing field of nanotechnology and its future use in cosmetic products holds both enormous potential and potential concern for consumers. Currently, major cosmetic manufacturers have imposed a voluntary ban on the use of nanoparticles in products while they await a ruling from the Food and Drug Administration (FDA) regarding the safety of this [...]

Also tagged Consumers, Cosmetic Manufacturers, Cosmetic Products, Fda, Food And Drug, Food And Drug Administration Fda, Nanoparticles, Nanosized Particles, Nanotechnology Future, Skin Care, Skin Care Products, Skin Products, Voluntary Ban

2010 03 05 Skin Care News Comments Off

Regulatory Science Update: FDA And International Serious Adverse Events Consortium Complete Third Data Release

The U.S. Food and Drug Administration and the International Serious Adverse Event Consortium (SAEC) announced the third release of data on the genetic basis of drug-induced liver injury (DILI) and serious skin reactions (SSRs). The data focus on the genetics associated with DILI and SSR and may help researchers to better predict an individual’s [...]

Also tagged Consortium, Dili, Fda, Food And Drug, Genetic Basis, Genetics, Liver Injury, Regulatory Science, Risk, Saec, Serious Adverse Event, Serious Adverse Events, Serious Skin, Skin Reactions, Ssr

2010 02 22 Skin Care News Comments Off

First Fractional Laser FDA Cleared For Striae

Palomar Medical Technologies, Inc. is pleased to announce that the Lux1540™ Fractional non-ablative laser handpiece has received the first clearance by the United States Food and Drug Administration (FDA) for the treatment of striae (stretch marks) using a fractional laser…

Also tagged Fda, Food And Drug, Food And Drug Administration Fda, Laser Handpiece, Medical Technologies Inc, Palomar Medical Technologies, Palomar Medical Technologies Inc, Stretch Marks

2010 02 05 Skin Care News Comments Off

Tanning Beds: FDA To Debate Tougher Cancer Warning

Advisors to the US Food and Drug Administration are planning hold a public debate in the spring to discuss the pros and cons of stricter regulations on the use of tanning beds, including stronger warnings on cancer risks and reclassifying them…

Also tagged Cancer Risks, Fda, Food And Drug, Pros And Cons, Public Debate, Tanning Beds, Us Food And Drug Administration

2010 01 19 Skin Care News Comments Off

FDA Issues Complete Response Letter For Ceftobiprole

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) announced it received a Complete Response letter from the U.S. Food and Drug Administration (FDA) for ceftobiprole. The New Drug Application (NDA) was originally submitted to the FDA in May 2007 for the treatment of complicated skin and skin structure infections (cSSSI), including diabetic foot [...]

Also tagged Amp, Ceftobiprole, Diabetic Foot Infections, Drug Application, Fda, Fda Issues, Food And Drug, Food And Drug Administration Fda, Jprd, Nda, Pharmaceutical Research, Response Letter, Skin And Skin, Skin Structure Infections

2010 01 06 Skin Care News Comments Off

FDA Approves New Drug For Pain That Persists After Shingles

The US Food and Drug Administration (FDA) announced yesterday that it has approved Qutenza (capsaicin) 8% patch for the treatment of post-herpetic neuralgia (PHN), an often excruciating pain that can persist for weeks, months and even years in 10 to 15 per cent of people who get shingles. [...]

Also tagged Andernach Germany, Excruciating Pain, Fda, Fda Approved, Food And Drug, Food And Drug Administration Fda, Neurogesx Inc, People, Post Herpetic Neuralgia, Shingles, Skin Patch, Therapie, Us Food And Drug Administration

2009 11 18 Skin Care News Comments Off

FDA Approves New Drug Treatment For Long-Term Pain Relief After Shingles Attacks

The Food and Drug Administration (FDA) has approved the approval of Qutenza (capsaicin) 8% patch, a medicated skin patch that relieves the pain of post-herpetic neuralgia (PHN), a serious complication that can occur after a bout with shingles. Shingles is an outbreak of rash or blisters on the skin that is caused [...]

Also tagged Blisters On The Skin, Chickenpox, Fda, Fda Approved, Food And Drug, Food And Drug Administration Fda, Outbreak, Pain Relief, Post Herpetic Neuralgia, Rash, Shingles, Skin Patch, Varicella, Varicella Zoster Virus

2009 11 18 Skin Care News Comments Off

Sol-Gel’s IND Application For Rosacea Accepted By FDA

Sol-Gel Technologies announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of Sol-Gel’s Investigational New Drug Application (IND) for DER45-EV Gel for the topical treatment of rosacea. This IND allows Sol-Gel to initiate Phase II studies with DER45-EV Gel in rosacea patients. DER45-EV Gel is an innovative topical product based [...]

Also tagged Drug Application, Drug Delivery System, Drugs, Efficacy, Fda, Food And Drug, Food And Drug Administration Fda, Phase Ii, Receipt, Rosacea Patients, Sol Gel, Topical Treatment

2009 11 13 Skin Care News Comments Off

Theravance And Astellas Announce The Commercial Launch Of VIBATIVTM (telavancin) In The United States

Theravance, Inc. (NASDAQ: THRX) and Astellas Pharma US, Inc. announced today the commercial launch of VIBATIV™ (telavancin) in the United States. On September 11, 2009, the U.S. Food and Drug Administration (FDA) approved VIBATIV for the treatment of adult patients with complicated skin and skin structure infections (cSSSI) caused by susceptible Gram-positive bacteria, including Staphylococcus [...]

Also tagged Adult Patients, Astellas Pharma Us, Astellas Pharma Us Inc, Fda, Food And Drug, Food And Drug Administration Fda, Gram Positive Bacteria, Launch, Mrsa, Nasdaq, September 11, Skin And Skin, Skin Structure Infections, Staphylococcus Aureus, Strains, Telavancin, Theravance Inc, Thrx, United States

2009 11 06 Skin Care News Comments Off

Fibrocell Science, Inc. Reports Outcome Of FDA Advisory Committee Meeting On Azfibrocel-T For Wrinkles

Fibrocell Science, Inc. (OTCBB: FCSC) announced that the U.S. Food and Drug Administration’s (FDA) Cellular, Tissue and Gene Therapies Advisory Committee reviewed azfibrocel-T, an autologous cell therapy being investigated for the treatment of moderate to severe nasolabial fold wrinkles in adults. The committee voted 11 yes to 3 no that the data presented on azfibrocel-T [...]

Also tagged Adults, Cellular Tissue, Committee Meeting, Efficacy, Fcsc, Fda, Fda Advisory Committee, Food And Drug, Gene Therapies, Otcbb, Science Reports, Wrinkles

2009 10 10 Skin Care News Comments Off

The Truth About Skin Care

{ Tag Archives } Food And Drug Administration

Sizing Up Nanotechnology: How Nanosized Particles May Affect Skin Care Products

Regulatory Science Update: FDA And International Serious Adverse Events Consortium Complete Third Data Release

First Fractional Laser FDA Cleared For Striae

Tanning Beds: FDA To Debate Tougher Cancer Warning

FDA Issues Complete Response Letter For Ceftobiprole

FDA Approves New Drug For Pain That Persists After Shingles

FDA Approves New Drug Treatment For Long-Term Pain Relief After Shingles Attacks

Sol-Gel’s IND Application For Rosacea Accepted By FDA

Theravance And Astellas Announce The Commercial Launch Of VIBATIVTM (telavancin) In The United States

Fibrocell Science, Inc. Reports Outcome Of FDA Advisory Committee Meeting On Azfibrocel-T For Wrinkles

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