Life Sciences Articles by Topic: FDA Regulations

FDA to review risks for older devices

• Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 13, April 13, 2009

  Manufacturers of 25 types of medical devices marketed prior to 1976 must submit safety and...

FDA warns pharma companies for online ads

• Pharma Compliance Alert, Issue 14, April 8, 2009

  Fourteen pharmaceutical companies received warning letters from the FDA for...

KV Pharmaceutical enters into consent decree with FDA

• Pharma Compliance Alert, Issue 9, March 4, 2009

  KV Pharmaceutical may soon resume manufacturing and marketing products after entering into a...

FDA levels new allegations against Ranbaxy plant

• Pharma Compliance Alert, Issue 9, March 4, 2009

  Ranbaxy Laboratories’ Paonta Sahib, India, facility falsified data and test results in...

Non-profit group criticizes FDA for ignoring GLPs

• Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 8, February 23, 2009

  The FDA is putting patient lives at risk by failing to enforce good laboratory standards (GLPs...

FDA warns Abbott for misleading promotion

• Pharma Compliance Alert, Issue 5, February 4, 2009

  Abbott Laboratories’ flashcard for Depakote and Depakote ER misbrands the drugs, according to...

Class III devices may require PMA

• Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 4, January 26, 2009

  Medical device manufacturers may soon be required to submit all class III devices to the more...

FDA finalizes guidance on reprints

• Pharma Compliance Alert, Issue 2, January 14, 2009

  Pharmaceutical and medical device manufacturers will find it easier to distribute journal articles...

FDA: HUMIRA ad misleading

• Pharma Compliance Alert, Issue 52, December 31, 2008

  Abbott’s American Academy of Dermatology post meeting news ad for HUMIRA misbrands the drug...

FDA warns Victory Pharma for misleading sales aid

• Pharma Compliance Alert, Issue 51, December 24, 2008

  A Victory Pharma sales aid minimizes risks, presents misleading safety information, and omits...

FDA warns AstraZeneca for alleged off-label promotion

• Pharma Compliance Alert, Issue 49, December 10, 2008

  An AstraZeneca sales representative allegedly promoted the company’s antipsychotic Seroquel...

Actelion receives FDA warning letter for flash card

• Pharma Compliance Alert, Issue 48, December 3, 2008

  A flash card for Actelion’s Tracleer tablets presents unsubstantiated superiority claims and...

FDA warns Protherics for Web page, fact sheet

• Pharma Compliance Alert, Issue 47, November 26, 2008

  Protherics Inc.’s Web page and fact sheet for its investigational new drug Voraxaze misbrand...

Shionogi direct mailers misleading, FDA says

• Pharma Compliance Alert, Issue 47, November 26, 2008

  Shionogi USA Inc.’s Professional NDC Sheet and a Cardinal Health NDC Sheet (direct mailers...

FDA issues special control guidance for condoms

• Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 47, November 24, 2008

  The FDA outlines labeling recommendations for natural rubber latex condoms without spermicidal...

Amgen brochure misleading, FDA warns

• Pharma Compliance Alert, Issue 44, November 5, 2008

  Amgen’s direct-to-consumer patient brochure for Senispar tablets improperly omits and...

J&J paid $68M to settle birth-control patch lawsuits

• Pharma Compliance Alert, Issue 41, October 15, 2008

  Johnson & Johnson paid at least $68.7 million to settle hundreds of lawsuits by women who claim...

FDA warns five companies for incomplete or false advertising

• Pharma Compliance Alert, Issue 39, October 1, 2008

  Shire, Johnson & Johnson, Novartis, Mallinckrodt, and Eli Lilly all received warning letters...

FDA issues warning letters to Ranbanxy

• Pharma Compliance Alert, Issue 38, September 24, 2008

  Two of generic drug manufacturer Ranbaxy’s plants allegedly violated U.S. current Good...

REMS represent big change for industry

• Pharma Compliance Alert, Issue 38, September 24, 2008

  Risk Evaluation and Mitigation Strategies (REMS) could represent the biggest change to drug...

Globalization one of FDA's emerging trends

• Pharma Compliance Alert, Issue 37, September 17, 2008

  The number of drug products manufactured overseas and the numbers of sites that manufacture drug...

Sandoz receives FDA warning letter

• Pharma Compliance Alert, Issue 35, September 3, 2008

  An FDA inspection revealed significant deviations from Good Manufacturing Practice at...