In a move aimed at speeding reviews of generics this year, the FDA released a new draft guidance on ANDAs for public comment along with an updated Manual of Policies…

The FDA issued a warning letter to Korean drug manufacturer Amaros, citing significant quality and GMP violations. Source: Drug Industry Daily

Australia’s Therapeutic Goods Administration issued revised guidelines for its comparable overseas regulators (CORs) program, designed to collaboratively regulate prescription medicines using an international report-based process. Source: Drug Industry Daily

The FDA approved 46 novel drugs in 2017, hitting a two-decade high after approvals plunged in the previous year — a record 53 novel drugs were approved in 1996. Source:…

A federal judge overturned a July verdict against AbbVie in a bellwether case involving AndroGel. Source: Drug Industry Daily

A new FDA draft guidance outlines clinical trial designs for treatments of male hypogonadotropic hypogonadism, including enrollment criteria and efficacy endpoints. Source: Drug Industry Daily

The FDA flagged a Shilpa Medicare facility in Telangana, India for numerous violations including noncompliant labeling, sterility procedures and testing methods. Source: Drug Industry Daily

C.O. Truxton drew a warning letter from the FDA for drug repackaging, labeling, complaint handling and product distribution. Source: Drug Industry Daily

ClinicalTrials.gov received a new set of usability updates last month, including additional local search functions, a new glossary feature and redesigned study record pages. Source: Drug Industry Daily

The Drug Enforcement Administration proposed listing fentanyl products as Schedule I controlled substances to help address the opioid crisis. Source: Drug Industry Daily