Pfizer Loses Suit Against Texas Agency Over Sharing Medicaid Data With Lawmakers
A Texas judge ruled state legislators are entitled to see details of Pfizer’s Medicaid pricing practices, denying a legal challenge by the drugmaker. Source: Drug Industry Daily
House Members Join Probe in Allergan-Mohawk Patent Deal
Republicans and Democrats on the House Oversight Committee pressed Allergan for an explanation of its decision to transfer patents for its lucrative dry-eye drug Restasis to a Mohawk tribe to…
HHS Delays 340B Rule Again, Indicates it May Drop it Per Trump Order
HHS has once again pushed back the effective date of its final rule that would institute fines for drugmakers who overcharge for products covered by a hospital discount program. Source:…
FDA Loosens Expanded Access Requirements as Gottlieb Testifies on Right-to-Try Bills
As federal right-to-try legislation gathers steam on Capitol Hill, the FDA rolled out measures to streamline its expanded access process — including loosening institutional review board requirements — and issued…
483 Roundup: Sterile Conditions Elude Drug Producers, FDA Says
Shortcomings in sterile drug processing landed three companies in trouble with the FDA, while a fourth was chastised for neglect of a customer’s complaint, as reflected in Form 483 inspection…
Expert Lists Data Integrity Red Flags for Drug Sponsors
Drug sponsors should ask themselves three data integrity questions before the FDA can, according to John Avellanet, managing director and principal consultant at Cerulean Associates, during an expert panel at…
UK Firms May Have Trouble Lifting Non-Compliance Marks Post-Brexit
The European Medicines Agency said it may become more difficult for UK firms to have GMP non-compliance statements lifted following Brexit. Source: Drug GMP Report
FDA Updates Guidelines on Quality Testing to Include Health Canada
The FDA updated several ICH guidance documents to reflect Canada’s adoption of interchangeable chapters from the U.S., European and Japanese pharmacopeias. Source: Drug GMP Report
Warning Letter Roundup: FDA Moves Against GMP Violators
Makers of compounded drugs, dietary supplements and OTC treatments, at home and abroad, drew warning letters from the FDA. Source: Drug GMP Report
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