Archive for September 2018
Congress Advances Reconciled Opioid Crisis Package
House and Senate conferees reached agreement late Tuesday on a final version of an expansive legislative package to address the opioid crisis. Source: Drug Industry Daily
Read MoreFDA Releases Guidance on Radiopharmaceutical Compounding at Outsourcing Facilities
The FDA issued final guidance Tuesday for outsourcing facilities on compounding and repackaging radiopharmaceuticals, along with draft guidance on insanitary conditions at compounding facilities. Source: Drug Industry Daily
Read MoreFDA Warns Indian OTC Facility for Quality Violations
The FDA issued a warning letter to Wilson Medicine Company citing serious quality problems found during a Feb. 26-March 1 inspection of its OTC manufacturing facility in Nandore, India. Source: Drug Industry Daily
Read MoreEMA Update: 25 Human Drugs at Risk of Brexit Supply Disruptions
The EMA lowered its estimate for the number of centrally authorized drugs that may face post-Brexit supply disruptions from 108 to 39 — including 25 human medicines. Source: Drug Industry Daily
Read MoreGilead to Launch Generics for Its Hepatitis C Drugs
Against a backdrop of declining sales for its branded hepatitis drugs, Gilead announced plans to launch its own “authorized generics” of two of its hep C treatments. Source: Drug Industry Daily
Read MorePhase III Trial Costs Estimated at $19 Million
It cost an average of $19 million to get new drugs through their pivotal clinical trials and onto the market, a new analysis has found. Source: Drug Industry Daily
Read MoreFDA Cites Buenos Aires API Facility for Records, Equipment Calibration
The FDA rapped Umicore Argentina for violations relating to its control procedures and equipment calibration, following a May inspection of the API manufacturer’s Buenos Aires facility. Source: Drug Industry Daily
Read MoreNew FDA Guidances Aim to Reduce Number of Review Cycles
The FDA released two new guidances Monday to help speed reviews of generic drugs and get the products to market more quickly. Source: Drug Industry Daily
Read MoreDrugmakers Seek Clarification on Use of Liquids, Foods as Drug Delivery Vehicles
Genentech and Boehringer Ingelheim want the FDA to amend or clarify parts of its draft guidance on the use of liquids or soft foods as drug administration vehicles. Source: Drug Industry Daily
Read MoreAllergan and St. Regis Mohawk Tribe Sue Amneal Over Generic Restasis ANDA
In the latest development in the ongoing saga over Allergan’s transfer of Restasis patents to a Native American tribe, the partners sued Amneal for infringing upon two patents for the dry-eye drug. Source: Drug Industry Daily
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