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Congress Averts Shutdown, for Now

  • Post author:Sam
  • Post published:April 28, 2017
  • Post category:Drug Industry Daily

Congress approved a continuing resolution Friday, averting a government shutdown for at least another week. Source: Drug Industry Daily

Continue ReadingCongress Averts Shutdown, for Now

House, Senate Re-Introduce Bill Targeting Generic Drug Suppression

  • Post author:Sam
  • Post published:April 27, 2017
  • Post category:Drug Industry Daily

House and Senate leaders re-introduced legislation Thursday to keep drugmakers from blocking generic competitors. Source: Drug Industry Daily

Continue ReadingHouse, Senate Re-Introduce Bill Targeting Generic Drug Suppression

Petition Calls for Sentinel Query on Off-Label Use of Ulcer Drug

  • Post author:Sam
  • Post published:April 27, 2017
  • Post category:Drug Industry Daily

A health advocacy group has petitioned the FDA to conduct a Sentinel query on off-label uses of misoprostol. Source: Drug Industry Daily

Continue ReadingPetition Calls for Sentinel Query on Off-Label Use of Ulcer Drug

Gottlieb Nomination Moves on to Full Senate

  • Post author:Sam
  • Post published:April 27, 2017
  • Post category:Drug Industry Daily

The confirmation of Scott Gottlieb as the next FDA commissioner moved one step closer yesterday after a Senate panel voted 14-9 in his favor. Source: Drug Industry Daily

Continue ReadingGottlieb Nomination Moves on to Full Senate

EMA Should Clarify Role in Collaboration on Non-EU Drugs, Officials Say

  • Post author:Sam
  • Post published:April 26, 2017
  • Post category:Drug Industry Daily

The European Medicines Agency plans to clarify its role regarding drugs manufactured in the EU solely for the export market. Source: Drug Industry Daily

Continue ReadingEMA Should Clarify Role in Collaboration on Non-EU Drugs, Officials Say

TGA Scraps 15-Day GMP Clearance Timeline, Expands to 30 Days

  • Post author:Sam
  • Post published:April 26, 2017
  • Post category:Drug Industry Daily

Australia’s Therapeutic Goods Administration is abandoning its goal of 15-day timelines to process GMP clearance filings from overseas manufacturers. Source: Drug Industry Daily

Continue ReadingTGA Scraps 15-Day GMP Clearance Timeline, Expands to 30 Days

Gottlieb Confirmation Vote Delayed

  • Post author:Sam
  • Post published:April 26, 2017
  • Post category:Drug Industry Daily

The U.S. Senate Committee on Health, Education, Labor and Pensions postponed a Wednesday vote on the nomination of Scott Gottlieb to be the next commissioner of the FDA. Source: Drug…

Continue ReadingGottlieb Confirmation Vote Delayed

Supreme Court to Decide on 180-Day Biosimilar Exclusivity, Early Notification

  • Post author:Sam
  • Post published:April 26, 2017
  • Post category:Drug Industry Daily

The U.S. Supreme Court is expected to rule by the end of June on a case that could affect how long it takes biosimilars to get to market. Source: Drug…

Continue ReadingSupreme Court to Decide on 180-Day Biosimilar Exclusivity, Early Notification

Fourteen Companies Land FDA Warnings for False Cancer Claims

  • Post author:Sam
  • Post published:April 25, 2017
  • Post category:Drug Industry Daily

The FDA has warned 14 companies for selling products that claim to treat cancer and other diseases. Source: Drug Industry Daily

Continue ReadingFourteen Companies Land FDA Warnings for False Cancer Claims

Divi’s Draws Warning Over GMP Problems

  • Post author:Sam
  • Post published:April 25, 2017
  • Post category:Drug Industry Daily

Divi’s Laboratories has been warned by the FDA for failing to meet current good manufacturing practice requirements, adding to the Indian drug manufacturer’s compliance woes. Source: Drug Industry Daily

Continue ReadingDivi’s Draws Warning Over GMP Problems
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