Biologics
A 3/23-5/4 FDA inspection at Amniotic Therapies, Farmers Branch, TX, found multiple violations in the firm’s receiving of amniotic tissue recovered from cesarean births and processing the amnion, a structural tissue, from donors for allogenic use. The firm also produces AlphaGEMS, AlphaGEMS Micro and AlphaGEMS Nano
Drugs
An improved FDA combination product review and approval system could help speed needed products to market, like generic copies of Mylan’s EpiPen that has drawn a lot of attention lately due to allegedly unwarranted price increases, Pharmaceutical Research and Manufacturers of America (PhRMA) argues in a new blog post.
Drugs
The California Supreme Court has ruled 4-3 that its state courts have jurisdiction over eight Bristol-Myers Squibb (BMS) product liability lawsuits involving the company’s blood thinner Plavix even though the plaintiffs are not residents of the state. “Although BMS’s business contacts in California are insufficient to
Drugs
Harvard Medical School researchers say that over the past two decades, fewer investigational cardiovascular drugs have entered clinical trials across all stages of development. Writing in JACC Basic to Translational Science, the researchers say, however, that recently more therapies have targeted novel biological pathways and have been sponsored by small
Drugs
The U.S. Pharmacopeial Convention says that an FDA draft guidance on elemental impurities in drug products “provides clarity and assistance to human drug product manufacturers regarding the control of elemental impurities consistent with implementation of International Council for Harmonization guidance for industry … and pursuant to the USP requirements for
FDA Policy/General
Federal Register Notice: FDA is making available a guidance entitled, Enforcement Policy on National Health Related Item Code and National Drug Code Numbers Assigned to Devices. It describes the agency’s intent to refrain from enforcing the prohibition against providing National Health Related Item Code or National Drug Code numbers
FDA Policy/General
Federal Register Notice: FDA will hold a meeting of the Vaccines and Related Biological Products Advisory Committee11/16, from 8:30 a.m. to 2:30 p.m. at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD.
FDA Policy/General
Federal Register Notice: CDER and CDRH are sponsoring a two-day conference entitled “FDA Small Business and Industry Assistance Regulatory Education for Industry (REdI) Fall Conference.” Its goal is to provide direct, relevant, and helpful information on the key aspects of drug and device regulations. The primary audience is that
FDA Policy/General
Federal Register Notice: FDA will hold a meeting of the Antimicrobial Drugs Advisory Committee 11/4, from 8:30 a.m. to 5 p.m. at FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD. The committee will discuss
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Amniotic Therapies, LLC Farmers Branch, TX (8/17). Inspected 3/23-5/4. CGMP deviations, adulterated: The amniotic-based products, which the firm describes as morselized, (purged) are also
Biologics
FDA has approved a Sandoz BLA for Erelzi, (etanercept-szzs) a biosimilar copy of Amgen’s Enbrel (etanercept), indicated for treating rheumatoid arthritis, plaque psoriasis, psoriatic psoriasis, ankylosing spondylitis and polyarticular juvenile idiopathic arthritis. Last month, the agency’s Arthritis Drugs Advisory Committee voted 20 to 0 to support the
Biologics
FDA has accepted for review a CSL Behring BLA for its low-volume subcutaneous CSL830 (C1-esterase inhibitor (C1-INH) human) replacement therapy for preventing hereditary angioedema (HAE) attacks. The rare genetic disorder is caused by a deficiency of C1-INH, one of the proteins that work with the immune
Drugs
FDA has published a final rule that requires drug/biologic makers to electronically submit, unless waived in certain circumstances, their registration and listing information. The 2006-proposed rule featured a requirement that FDA, not registrants, develop national drug codes (NDCs) for assignment to listed drugs, and a requirement that the
FDA Policy/General
Federal Register Notice: FDA is making available a revised draft guidance for industry on generic risperidone injection, entitled Bioequivalence Recommendations for Risperidone. It provides specific guidance on the design of bioequivalence studies to support ANDAs for risperidone injection. To download this guidance, click here. To view this notice, click here.
Drugs
House Energy and Commerce Committee leaders have written FDA asking for details on what the agency can do to expedite generic copies of Mylan’s EpiPen Auto-Injector (epinephrine injection) amid growing criticism of cost increases related to the product. The letter asks FDA to provide details on how many
Devices
FDA has released a final guidance on “Enforcement Policy on National Health Related Item Code and National Drug Code Numbers Assigned to Devices.” The guidance describes the agency’s enforcement of a prohibition against providing National Health Related Item Code or National Drug Code numbers on device labels and device
FDA Policy/General
Federal Register Notification of withdrawal: FDA is withdrawing approval of eight new animal drug applications at the sponsor’s request because these products are no longer manufactured or marketed. Elanco Animal Health has requested that FDA withdraw approval of the NADAs such as Tylosin/Hygromix, Tylan TM Type A medicated
Drugs
FDA has posted a draft guidance on Bioequivalence Recommendations for Risperidone that outlines recommended bioequivalence testing for ANDA sponsors seeking approval for a generic copy of Jannsen’s antipsychotic Risperdal. The document recommends an in vitro drug release study and an in vivo two-period, crossover steady-state study. The
Devices
Cook Medical has begun a Class 1 recall of its Roadrunner Uniglide Hydrophilic Wire Guide due to potential coating contamination with glass particles. The devices are constructed from a steerable, metallic core with a polymer coating, and a hydrophilic coating is applied over the radiopaque polymer jacket, according to a
Drugs
Faced with mounting criticism over its costly EpiPen Auto-Injector (epinephrine injection), Mylan now says it will launch an authorized generic of the product that will be discounted 50% of the branded product’s list price. “The authorized generic will be identical to the branded product, including device functionality and
Drugs
Impax Laboratories has recalled one lot of lamotrigine orally disintegrating tablets (ODT) 200 mg (Lot # 502240) due to a packaging error. The unit-of-use blister packs (a 10-count blister card contained in a single plastic shell-pack) may contain 100 mg product instead of the 200 mg product,
Drugs
Hybrid Pharma (Deerfield Beach, FL) has been cited in an eight-page Form-483 after a July inspection found that the firm had inadequate procedures designed to prevent microbiological contamination of drug products purporting to be sterile. The inspection also found the firm’s aseptic processing deficient regarding the system