Generic drug makers would like a single point of contact for all four offices involved in inspections, an industry official told the GPhA Fall Technical Conference. Read More

Wrong telephone numbers, unsecure email addresses and inconsistent sponsor names are among the common mistakes the FDA sees in regulatory submissions for generics that can trigger delays in the review process. Read More

The International Council for Harmonization has identified the key scientific issues pediatric drug developers must address early on to improve the prospects for a drug’s approval later in the development process, in a draft that updates a 16-year-old efficacy guideline. Read More

The British government is granting a new accelerated pathway for treatments likely to provide a significant benefit. Read More

The FDA will release biosimilar interchangeability guidelines on schedule by the end of the year, CDER Director Janet Woodcock confirmed yesterday. Read More

A congressman wants answers on why a pharmaceutical company has increased the price of a medication used to treat lead poisoning in Flint, Mich., the latest in a string of challenges by legislators to drug company pricing. Read More