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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the past week, the FDA issued final guidance for waivers, exceptions, and exemptions from Section 582 of the FD&C Act, draft guidance for previously approved antiretrovirals for treatment of HIV, and modifications to the list of recognized consensus standards.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
CDRH is accepting and holding in-person meetings with stakeholders and also offering hybrid in-person and virtual – meeting options, Director Jeff Shuren said in a statement Wednesday updating the industry on its return to post-COVID normalcy. 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
Quidel Cardiovascular’s recall of Quidel Triage Cardiac Panels, used to diagnose a heart attack, has been deemed class I by the FDA, the most serious type of recall as use of the device may cause injury or death. 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
Stryker received an FDA Form 483 after a Jan. 17-24 inspection of its Portage, Mich., plant showed that the company did not have a formal unit to receive, review and evaluate complaints about its C2 Nerve Monitor device. 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
The FDA has released a final guidance spelling out when and how drugmakers may seek a waiver, exception or exemption from its regulations as permitted by the Drug Supply Chain Security Act (DSCSA) while a bipartisan group of House lawmakers is pressing the FDA on whether the industry is prepared for the final stage of the act’s implementation. Read More
The FDA is accepting proposals to host in-person or remote visits to allow CDRH staff the opportunity to gain real-world knowledge through the CDRH Experiential Learning Program (ELP). Read More
Savings to the federal government from minimum discounts will only accrue to $1.8 billion against Congressional Budget Office’s estimate of $3.7 billion in the upcoming implementation of the drug savings elements of the Inflation Reduction Act (IRA), according to a recent study published in the Journal of Managed Care + Specialty Pharmacy. Read More