FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “PHS Guideline on Infectious Disease Issues in Xenotransplantation” (OMB Control Number 0910-0456). The guideline identifies general principles for preventing and controlling infectious diseases associated with xenotransplantation that may pose a risk to public health. It also
FDA Policy/General
Updated fiscal year (FY) 2021 FDA enforcement and compliance data show just how badly Covid-19 has decimated the agency’s Warning Letter issuance and inspections conducted, among other compliance actions. Of course, when the agency stopped both domestic and foreign inspections in 2020, it was expected to have a
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products. The updated document is intended to describe hearing aids, personal sound amplification products, their respective intended uses, and the regulatory requirements that apply to them. To view the
FDA Policy/General
Federal Register proposed rule: FDA is proposing to establish a regulatory category for over-the-counter (OTC) hearing aids and to make related amendments to update the regulatory framework for such devices. Specifically, it seeks to define OTC hearing aids and establish applicable requirements; amend existing rules for consistency with
FDA Policy/General
Federal Register notice: FDA is amending the animal drug regulations to reflect application-related actions for new animal drug applications, abbreviated new animal drug applications, and conditional new animal drug applications during January, February, and March. FDA is also informing the public about the availability of basis of approval summaries
FDA Policy/General
Sen. Richard Blumenthal (D-CT) says he will likely oppose Duke University School of Medicine professor Robert Califf’s potential nomination to be the next FDA commissioner. Califf’s name is the latest to be floated for the agency top job (see earlier story). Califf was commissioner for less than
FDA Policy/General
Drug Distribution Security Public Meeting 10/14/2021 Federal Register notice: FDA has announced an 11/16 virtual public meeting entitled “Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act (DSCSA).” The meeting is intended to provide stakeholders an opportunity to discuss enhanced drug
FDA Policy/General
BIOLOGICS FDA has approved a CSL Behring BLA for Afstyla [antihemophilic factor (recombinant), single chain], a factor VIII single-chain therapy for adults and children with hemophilia A. The company says it is the first and only single-chain product for hemophilia A that is specifically designed for long-lasting
FDA Policy/General
Luminex Corp. and Nanosphere have entered into a definitive agreement under which Luminex will acquire Nanosphere for $1.35 per share in an all cash transaction valued at about $58 million. Nanosphere says it will deliver proprietary diagnostic tools for detecting respiratory, gastroenteric and bloodstream infections. Allergan and Gedeon Richter
FDA Policy/General
FDA needs a deputy commissioner for regulatory competitiveness to “aggressively develop, coordinate, and drive agency initiatives that allow new medical products and technologies to come to market faster and less expensively — without sacrificing sound regulatory science.” So argues former FDA associate commissioner for external relations and now Center for Medicine
FDA Policy/General
Federal Register notice: FDA has announced an 11/16 virtual public meeting entitled “Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act (DSCSA).” The meeting is intended to provide stakeholders an opportunity to discuss enhanced drug distribution security requirements of the DSCSA related to
FDA Policy/General
Three sources have told the Washington Post that the White House is close to naming former FDA commissioner Robert Califf to the position again. The Post says that under federal law Biden faces a mid-November deadline to either nominate acting commissioner Janet Woodcock or name someone else to the
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled Select Updates for Unique Device Identification: Policy Regarding Global Unique Device Identification Database Requirements for Certain Devices. The document identifies certain Class 1 devices for which FDA does not intend to enforce Global Unique Device Identification Database submission requirements.
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled Q13 Continuous Manufacturing of Drug Substances and Drug Products. The International Council for Harmonization document provides clarification on continuous manufacturing concepts and describes scientific approaches and regulatory considerations. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has announced a 10/26 Vaccines and Related Biological Products Advisory Committee meeting. Panel members are scheduled to review and discuss Pfizer-BioNTech’s emergency use authorization amended request to administer their Covid-19 mRNA vaccine to children aged five through 11 years of age. To
FDA Policy/General
Responding to media reports that Biotechnology Innovation Organization (BIO) CEO Michelle McMurry-Heath is one of President Joe Biden’s leading candidates to be named FDA commissioner, Public Citizen and 25 other groups are voicing their “strong opposition.” In a 10/12 letter to Biden, the groups say the commissioner
FDA Policy/General
Labeling Recommendations for Surgical Staplers 10/8/2021 Federal Register notice: FDA has announced a final guidance entitled Surgical Staplers and Staples for Internal Use — Labeling Recommendations. The labeling recommendations are intended to address device malfunctions and misuse. To view the notice, click here. Surgical Staplers Up-classified to Class
FDA Policy/General
DRUGS FDA has approved a Serenity Pharmaceuticals NDA for Noctiva (desmopressin acetate) nasal spray for adults who awaken at least two times per night to urinate due to a condition known as nocturnal polyuria (overproduction of urine during the night). Approval was based on data from two 12-week trials
FDA Policy/General
Sevion Therapeutics and Eloxx Pharmaceuticals, a clinical stage company developing therapeutics for genetic diseases caused by non-sense mutations, have agreed to an acquisition transaction. Under the agreement, Eloxx will become a wholly owned subsidiary of Sevion. Bristol-Myers Squibb and Qiagen have entered into an agreement to explore using
FDA Policy/General
Federal Register notice: FDA has announced a final guidance entitled Surgical Staplers and Staples for Internal Use — Labeling Recommendations. The labeling recommendations are intended to address device malfunctions and misuse. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has issued a final order to reclassify surgical staplers for internal use from Class 1 (general controls) into Class 2 (special controls) and subject to premarket review. The agency is issuing the reclassification on its own initiative based on new information. Between 1/2011 and 3/
FDA Policy/General
Federal Register notice: FDA has announced a 10/14-15 Vaccines and Related Biological Products Advisory Committee meeting. On 10/14, panel members will discuss an emergency use authorization (EUA) for Moderna’s Covid–19 mRNA vaccine for administering a booster dose in individuals 18 years of age and older.