Drugs
FDA has published a guidance, Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products — Content and Format, to help ensure that applicants include in the Dosage and Administration section of proposed labeling all the information needed for safe and effective dosing and administration of a drug
Devices
FDA says it is making minor updates to two Covid-19 testing guidances to help ensure continued access to tests while encouraging the transition of the tests to traditional premarket review pathways. An agency notice says the two affected guidances are Policy for Coronavirus Disease-2019 Tests (Revised) and Policy
Drugs
FDA has granted Qualigen Therapeutics an orphan drug designation for QN-302 and its use in treating pancreatic cancer. QN-302 is described as a small molecule selective transcription inhibitor with strong binding affinity to G4s prevalent in cancer cells. “Pre-clinical in-vitro and in-vivo studies of QN-
Drugs
Oramed Pharmaceuticals says it is discontinuing clinical development of its Type 2 diabetes drug ORMD-0801 after a Phase 3 clinical trial (ORA-D-013-1) missed its primary and secondary endpoints. The trial enrolled 710 Type 2 patients who experienced inadequate glycemic control on two or three oral glucose-
Drugs
FDA has signed an Agreement on Mutual Recognition between the Swiss Confederation and the U.S. relating to pharmaceutical good manufacturing practice. A 1/12 notice to international colleagues says FDA and the Swiss Agency for Therapeutic Products will be able to use each other’s good manufacturing practice inspections
Devices
CDRH Office of Strategic Partnerships and Technology Innovation director Suzanne Schwartz says the agency is working to implement provisions in the recently-approved omnibus spending bill giving FDA authority to require medical device manufacturers to address cybersecurity issues. In an online interview with HealthcareInfoSecurity, Schwartz said the agency has spent
Devices
Researchers from three academic medical centers say the National Committee on Vital and Health Statistics (NCVHS) should approve a proposal to modify health service claims forms to include medical device unique device identifiers (UDIs). Writing in a BMJ opinion piece, the researchers say medical device safety in the U.S.
Biologics
FDA has issued Biocon Biologics a complete response letter on its BLA for a biosimilar version of insulin aspart. The letter cites additional data needing to be submitted and confirmation that a corrective and preventive action plan has been implemented to address findings from a preapproval inspection at two Bangalore,
Biologics
Physician advocacy group Doctors for America is urging FDA to commit to convening an advisory committee meeting when it is time to consider the full approval of Biogen/Eisai’s Alzheimer’s therapy Leqembi (lecanemab).The group says it was concerned about the recent FDA decision to “expeditiously approve lecanemab
Devices
FDA inspections at two Olympus medical device manufacturing facilities in Japan led to separate Warning Letters. A just-released 12/12/22 Warning Letter was issued to Olympus Medical Systems Corp. following a 9/6-9/9/22 inspection at the firm’s Tokyo, Japan, facility that manufactures gastrointestinal and
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says it has some concerns about the practical implementation of the International Council for Harmonization Q12 guidance on implementation considerations for FDA-regulated products. It also says it has concerns about the implications for industry’s ability to maintain global submission. In a
Devices
FDA has released a draft guidance entitled “Photobiomodulation (PBM) Devices — Premarket Notification 510(k) Submissions.” The document provides draft recommendations for 510(k) submissions for PBM devices (also known as low level light therapy devices), which are intended for use in applications such as esthetics, dermatology, and other general indications.
Drugs
FDA has approved an AstraZeneca NDA for Airsupra (albuterol/budesonide) for the as-needed treatment or prevention of bronchoconstriction and to reduce the risk of exacerbations in people with asthma aged 18 years and older. The pressurized metered-dose inhaler contains a short-acting beta2-agonist (albuterol) and an anti-
Biologics
Some members of FDA and Centers for Disease Control vaccine advisory committees are “angry” and “disappointed” that neither the government nor Moderna presented some Moderna Covid-19 booster shot infection data when the advisors considered at meetings in 6/2022 and 9/2022 whether the booster should be authorized and
FDA Policy/General
[Commentary by Jim Dickinson, Editor] It has been discussed for decades and doubtless comes hard to those who respect heritage, but we agree with the Washington Post’s editorial board: the time has come for FDA to relieve itself of its Center for Food Safety and Applied Nutrition (CFSAN) so
Devices
An FDA Office of Criminal Investigations probe has resulted in guilty pleas by Jennifer Robertson (Battle Creek, MI) and Michelle McAllister (Jerome, MI) over their participation in a multi-year, interstate conspiracy to transport and traffic diabetic test strips stolen from the Battle Creek Veterans Affairs Medical Center. The test
Devices
Researchers from several academic medical centers say that among 156 medical devices cleared through the 510(k) pathway and subject to a Class 1 recall from 2017 through 2021, 44.1% were authorized using predicates that were also subject to Class 1 recalls. Devices authorized using these predicates were 6.
Drugs
A SheppardMullin report on “2023 Top-of-Mind Issues for Life Sciences Companies” looks at several FDA issues as well as other federal agencies. In 2022, the report says, the CDER Office of Prescription Drug Promotion (OPDP) continued its downward trend in enforcement, issuing just one Warning Letter and three
Drugs
A 4/26-5/9/22 FDA inspection at the Sun Pharmaceutical Industries drug manufacturing facility in Gujarat, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 12/15/22 Warning Letter says specific violations were: * failing to establish and follow appropriate
Drugs
CDER Office of Medication Error Prevention and Risk Management director Claudia Manzo says stakeholders have observed that the older REMS (risk evaluation and mitigation strategy) document format was not standardized or structured and generally could not be easily searched, queried, or managed. They suggested using structured product label (SPL) as
Drugs
FDA has released a six-item Form FDA-483 that cites analytical laboratory Valisure over deficient laboratory practices after a 5/26-7/6/22 agency inspection. The inspection led to a 12/5 untitled letter involving testing issues associated with the lab, which was behind the identification of several
Biologics
Constantly changing Covid-19 transmissible variants present a “major challenge” for current Covid vaccines, and continuing to develop variant-specific vaccine boosters is “inadequate as a long-term strategy for addressing Covid-19 in populations globally,” writes CDER director Peter Marks and two researchers from Brown University in a 1/