Drugs & Biologics

• Hyperion's Ravicti wins FDA approval for rare urea cycle disorders
  The FDA has approved Hyperion Therapeutics' Ravicti, or glycerol phenylbutyrate, to treat patients ages 2 and older with urea cycle disorders. The treatment, which holds an orphan-drug status, should be combined with a protein-restricted diet and possibly dietary supplements, the FDA said. PhysiciansBriefing.com/HealthDay News (2/1), Reuters (2/1)

• Agency releases final Sunshine Act rule
  CMS on Friday released the final rule for the Physician Payments Sunshine Act, requiring drug and device companies to gather information on gifts, payments and other value transfers provided to doctors and teaching hospitals starting Aug. 1. The rule also requires manufacturers and group purchasing organizations to report ownership and investment interests by physicians. Modern Healthcare (subscription required) (2/1)

• House GOP sets deadline for FDA data on NECC-tied outbreak
  Republicans on the House Energy and Commerce Committee could issue a subpoena if the FDA fails to produce by Feb. 25 key internal memos regarding the meningitis outbreak tied to the New England Compounding Center. "FDA has produced no communications from staff and officials at FDA headquarters, who were actually making the decisions about how to address the situation," committee chairman Fred Upton, R-Mich., and four other Republicans wrote in a letter to the agency. FDA spokeswoman Erica Jefferson said the agency had provided more than 3,500 pages and is preparing on a response to the panel. USA Today/The Associated Press (2/1), Reuters (2/2)

• FDA warns against excessive use of acetaminophen
  People who take more than one over-the-counter drug containing acetaminophen and exceed the recommended daily dose are at risk of liver damage, and may develop flu- or cold-like symptoms, the FDA said. The agency also warned about the risk of combining alcohol and acetaminophen. HealthDay News (1/30)

• India backs EMA's exposure limit for drug production in shared venues
  Indian drugmakers support the European Medicines Agency's guideline on health-based exposure restrictions for use in ascertaining the risks of making different treatments, such as cytotoxic drugs, hormones or antibiotics, in the same plant, according to a regional drug manufacturing group. PharmaBiz.com (India) (2/4)

• Bayer acne treatment's safety is scrutinized in Canada
  Health Canada is examining data on Bayer's acne treatment Diane-35 after it was banned in France following the deaths of four women in a quarter-century. People with clotting risk factors such as being overweight or smoking should not use Diane-35, the agency said. CTV.ca (Canada)/The Canadian Press (2/1)

Food & Dietary Supplements

• Listeria risks lead to recall of Gold Coast crab spread
  Giant Food announced it has pulled Gold Coast Fresh Crab Spread over concerns about Listeria monocytogenes. Affected packages have an expiration date of Jan. 31 and the Universal Product Code 83355500325. Food Business Review (2/4)

Medical Devices

• CMS issues plans to expand Medicare competitive bidding
  The CMS has issued plans for expanding competitive bidding for durable medical equipment, orthotics, prosthetics and supplies. The initiative's focus is "saving money for taxpayers and beneficiaries while preserving access to quality products from accredited suppliers," according to the CMS, but suppliers feel the program, along with a 2.3% tax, is squeezing the industry. New prices are set to take effect July 1. Clinica (subscription required) (2/1)

• Expanded Medicare bidding gets pushback from AdvaMed
  The Advanced Medical Technology Association has expressed concern over the CMS' decision to push ahead with pilot efforts to expand competitive bidding for durable medical devices. "The competitive bidding program is built in such a way that the lowest bid -- which may not be the right bid -- may compromise patient access to products best suited for their needs," AdvaMed President Stephen Ubl said. MassDevice.com (Boston) (2/1)

• Edap seeks FDA approval for prostate cancer device
  Edap TMS, a medical device firm based in France, has submitted to the FDA a premarket approval application for its Ablatherm-HIFU system. The high-intensity focused ultrasound system is intended for the noninvasive treatment of patients with localized, low-risk prostate cancer. MassDevice.com (Boston) (2/1)

• CryoLife gets warning letter over manufacturing concerns
  The FDA has issued a warning letter to CryoLife saying that the company failed to sufficiently fix earlier issues regarding manufacturing practices tied to some of its products. CryoLife will cooperate with the FDA in addressing the concerns raised in the letter, according to the company, which develops surgical devices and instruments. Reuters (2/1)

Hot Topics

Top five news stories selected by FDLI SmartBrief readers in the past week.

• FDA will let Pa. university put morning-after pills in vending machine (The Hill)

• Makers of combo drugs petition FDA on exclusivity period (Pharmalot.com)

• Overactive bladder drug wins OTC approval, but only for women (Reuters)

• Issues remain after FDA panel endorsed tighter pain drug restrictions (Pharmalot.com)

• FDA warns of liver injury risk from tolvaptan (Medscape (free registration))

• Results based on number of times each story was clicked by readers.

FDLI Items

• Food Week 2013 starts tomorrow! -- Still time to register
  FDLI's Food Week 2013 program is a unique opportunity for food law, regulation and policy stakeholders to hear first-hand from government officials and industry experts on the latest legal and regulatory developments. Food Week 2013 is a collection of four advanced one-day conferences, as well as FDLI's industry standard "Introduction to Food Law and Regulation" course. At this unique program, you set the menu -- attend one, two, three or all four conferences to make the most of your Food Week 2013 experience.
  • Conference No. 1, Tuesday: Hot Topics: Food & Politics; Food Regulation & GRAS; Food Stakeholders & Social Media; Food Trucks & Business
  • Conference No. 2, Wednesday: Food Advertising, Labeling, and Nutrition: What to Expect in 2013
  • Conference No. 3, Thursday: Food Safety: Latest Regulatory Developments & Best Practices
  • Conference No. 4, Friday: Global Developments: What's Your GPS
  • Introduction to Food Law and Regulation will take place Tuesday-Wednesday, the first two days of the advanced conferences.
  

Position Title Company Name Location FDA/ORA/Asst Commissioner for Operations, Food and Drug Administration, Office of Regulatory Affairs Food and Drug Administration Rockville, MD FDA/ORA/Regional Food and Drug Director Food and Drug Administration/Office of Regulatory Affairs Multiple Locations, United States FDA Associate K&L Gates Multiple Locations, United States Sales Engineer 108473-02 UTC Climate, Controls & Security Carrier Corporation Austin, TX Food and Drug Associate Hunton & Williams LLP Washington, DC

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Never assume the obvious is true." --William Safire, American author, columnist and presidential speechwriter