We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The growing burden of rebates and discounts has left drugmakers “underwater” on manufacturing inexpensive, generic cancer drugs, and has significantly harmed the supply chain for these treatments, the Community Oncology Alliance (COA) said in a recent statement. Read More
As the 118th Congress continues, FDAnews will track important pending legislation to keep you updated on laws and regulations that could impact your business. Read More
Following recent tornado damage to its Rocky Mount, N.C., manufacturing facility, Pfizer announced emergency ordering procedures to manage inventory for 12 formulations of nine drugs. Read More
More than two dozen lawmakers signed onto a letter pressing the FDA on what steps it is taking to “minimize the potential for disruptions to supply and patient care” as deadline for implementation of the DSCSA nears. Read More
Over the past week, the FDA issued final guidance for waivers, exceptions, and exemptions from Section 582 of the FD&C Act, draft guidance for previously approved antiretrovirals for treatment of HIV, and modifications to the list of recognized consensus standards. Read More
The FDA and the European Medicines Agency (EMA) have both issued guidances on various aspects of detecting, measuring, limiting and avoiding the presence of nitrosamine impurities in pharmaceuticals. Read More
An extended-release (ER) generic lamotrigine, used to treat epilepsy, is bioequivalent to GSK’s Lamictal, the FDA has determined — a finding that opens the way for pharmacy-level substitution of any generic ER lamotrigine product for the brand name. Read More
LXR Biotech received a warning letter from the FDA for having methods, facilities, controls for manufacturing, processing or holding its drug product that do not conform to GMPs, after the company’s response to a Form 483 included a statement that it no longer manufactures drugs. Read More
The FDA slapped Iso-Tex with a Form 483 following a Jan. 30 – Feb. 10 inspection because the radiopharmaceutical manufacturer failed to prevent microbiological contamination of drug products at its Alvin, Tex., plant. Read More
The FDA released a Form 483 from a May 4-12 inspection conducted at Catalent’s Bloomington, Ind., facility pointing to continuing woes for the plant and its customers, with observations of a lack of written production and process control procedures, inadequate equipment revalidation and inadequate cleaning. Read More