The FDA issued two guidances on postmarketing safety reporting for combination products, pushing back reporting requirements for certain combination products and clarifying reporting rules for their constituent parts. Source: Drug…
The FDA cited five drugmakers for problems relating to training, unsanitary conditions, document handling and other deficiencies. Source: Drug GMP Report
The FDA issued warnings to three overseas and two U.S. facilities for a variety of nonconformances including inadequate testing. Source: Drug GMP Report
The House passed an omnibus spending bill on March 22 that boosts FDA funding for medical product safety activities by $113.2 million, including a one-time payment of $94 million to…
HHS should claim five patents on Serepta Therapeutics’ Exondys 51 (eteplirsen), a drug used to treat Duchenne muscular dystrophy, and use the patents as leverage to lower the drug’s price,…
CDER’s Office of New Drugs issued a new manual of policies and procedures, effective immediately, concerning NDAs for parenteral drugs that will be packaged in plastic immediate containers. Source: Drug…
The FDA published a new draft guidance outlining how early sponsors should incorporate pediatric patients, and the relevant age groups, for systemic therapies for atopic dermatitis. Source: Drug Industry Daily
FDA drug fraud investigations increased by nearly 50 percent in fiscal 2017 reaching an all-time high since the agency began participating in the Health Care Fraud and Abuse Control Program…
FDA issued a warning letter to Biotek after a review of its website found some of its products were intended for use as drugs. Source: Drug Industry Daily
Health Canada adopted the ICH’s Q&A guideline on the development and manufacture of drug substances as well as a separate guidance on residual solvents. Source: Drug Industry Daily