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The European Commission will revise four chapters of its good manufacturing practice guideline and add a new one, as it moves to harmonize GMPs with international standards and speed the path to mutual reliance with foreign regulators, a UK official says. Read More
The number of critical deficiencies at pharma facilities registered in the UK nearly doubled from 2012 to 2013, spurred mainly by problems with data integrity, regulators say. Read More
A federal judge dealt Otsuka a blow, dismissing claims that the FDA is precluded from approving generic versions of its blockbuster antipsychotic Abilify until its orphan exclusivity runs out in December 2021. Read More
The FDA is working rapidly to establish a mutual inspection program with the EU that uses similar GMPs and quality metrics, CDER Director Janet Woodcock said June 1, adding that the current system of different expectations is not sustainable. Read More
Two prominent lawmakers are following through on a promise to do something about recent rises in generic drug prices, with identical House and Senate bills that would force generic drugmakers to pay state Medicaid rebates when prices rise faster than inflation. Read More
A federal appeals court last month affirmed a lower court order preventing Actavis from replacing an older formulation of Namenda ahead of generic versions of the Alzheimer’s drug hitting the market in July. Read More
The FDA is clarifying its definition of “established conditions” to ensure drugmakers properly report postapproval chemistry, manufacturing and control changes in NDAs, ANDAs and BLAs. Read More
If the FDA were to implement a quality metrics program similar to the collection of 16 metrics used in ISPE’s Quality Metric Pilot Program, the cost would be about $75,000 annually per company, or $35 million across the industry, ISPE says. Read More
Cephalon has agreed to pay the federal government $1.2 billion to settle antitrust allegations that it illegally blocked competition to Provigil by paying generics makers to hold off on their versions of the blockbuster narcolepsy drug. Read More
For the second time in two days, the FDA has recommended approval of a PCSK9 inhibitor as an effective and relatively safe means of lowering bad LDL cholesterol. Read More
The Goldwater Institute is suing the FDA after it denied the group’s Freedom of Information Act request for information on the process the agency used in allowing two Americans to be treated with an investigational anti-Ebola drug. Read More