Archive for June 2019
Glenmark Draws Complete Response Letter for Allergy Spray
Glenmark Pharmaceuticals said it is “confident” that it can get its investigational allergy spray Ryaltris back on track after the FDA pulled the brakes on its application in the form of a complete response letter. Source: Drug Industry Daily
Read MoreCongress Seeks GAO Review of Foreign Drug Inspection Program
Ongoing recalls of contaminated blood pressure drugs prompted the House Energy and Commerce Committee to call on Friday for a review of the FDA’s foreign drug inspection program. Source: Drug Industry Daily
Read MoreFDA Issues Guidance on Developing Drugs to Treat Epidermolysis Bullosa
The FDA released final guidance for sponsors of drugs to treat or prevent serious flare-ups of skin disorders known collectively as epidermolysis bullosa (EB). Source: Drug Industry Daily
Read MorePfizer Bags a New Biosimilar — and a Former Commissioner
In a big week for Pfizer, the world’s second largest drugmaker earned the FDA’s approval for a biosimilar cancer treatment and signed up the agency’s former Commissioner Scott Gottlieb for its board. Source: Drug Industry Daily
Read MoreCBER Flags Planned Gene Therapy Guidances for 2019
CBER released an updated list of guidances it plans to publish this year, including draft recommendations on the following gene therapy topics: Source: Drug Industry Daily
Read MoreFDA Proposes New Rule Formalizing Master Files for BLAs
The FDA released a proposed rule to codify the use of master files for biologics applications. Source: Drug Industry Daily
Read MoreFDA Considers How Heart Patients Feel, Function, in New Draft Guidance
Regulators might be willing to approve heart failure drugs that make patients feel better even if they don’t keep patients out of the hospital — or even alive, the FDA said in a new draft guidance document issued Thursday. Source: Drug Industry Daily
Read MoreCanada Details New User Fees for Devices
Health Canada is increasing fees for device sponsors and will peg ongoing increases to inflation, the agency said in a final report on the planned changes. Source: The GMP Letter
Read MoreSenator Demands Answers From Companies Over Duodenoscopes
Washington Democratic Sen. Patty Murray is demanding answers from the leaders of three device companies at the center of an ongoing FDA investigation of contaminated duodenoscopes that regulators worry are spreading deadly bugs. Source: The GMP Letter
Read MoreFDA Issues Alert for Beckman Coulter Blood Analyzers
The FDA issued an alert over a recall of Beckman Coulter DxH 800, DxH 600 and DxH 900 blood analyzers, updating an urgent medical device correction letter the company issued following complaints of inaccurate blood platelet counts. Source: The GMP Letter
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