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Gottlieb's FDA

July 18, 2018 |

FDA released a long-awaited Biosimilars Action Plan Wednesday (July 18) that promises new development tools for biosimilars makers, additional educational resources and a public hearing dedicated to biosimilar competition, among other initiatives.

July 18, 2018 | Daily News

FDA released a long-awaited Biosimilars Action Plan Wednesday (July 18) that promises new development tools for biosimilars makers, additional educational resources and a public hearing dedicated to biosimilar competition, among other initiatives.

July 18, 2018 | Daily News

The House Energy & Commerce health subcommittee on July 25 will hear from FDA Commissioner Scott Gottlieb and National Institutes of Health Director Francis Collins about the work being done to implement provisions of the 21st Century Cures Act, the subcommittee announced Wednesday (July 18).

July 18, 2018 | Daily News

FDA approved new uses of a cancer drug using two new pilot review programs that aim to streamline the review of cancer drugs and improve the standards for evaluating safety and efficacy, the agency announced Wednesday (July 18).

July 18, 2018 | Daily News

FDA commissioner Scott Gottlieb said his agency will soon open a docket to receive public comment on whether non-dairy products can be marketed as milk, stepping into a heated debate between the dairy industry and those marketing non-dairy milk.

July 18, 2018 |

FDA, in a bid to expand use of nonprescription drugs, issued a draft guidance Tuesday (July 17) that proposes two new ways sponsors could demonstrate the safety and effectiveness of nonprescription drugs: providing supplemental information about a drug beyond what is included on the drug facts label (DFL) and requiring consumers meet certain criteria before being allowed to purchase the product.

July 17, 2018 | Daily News

FDA, in a bid to expand use of nonprescription drugs, issued a draft guidance Tuesday (July 17) that proposes two new ways sponsors could demonstrate the safety and effectiveness of nonprescription drugs: providing supplemental information about a drug beyond what is included on the drug facts label (DFL) and requiring consumers meet certain criteria before being allowed to purchase the product.

July 17, 2018 | Daily News

FDA, through its Drug Shortages Task Force, will work with CMS to revamp reimbursement policies for critical access drugs, especially sterile injectables, to incentivize manufacturers to invest in and modernize their manufacturing processes and spur development of critical access drugs, FDA Commissioner Scott Gottlieb said during a policy summit on Tuesday (July 17).

July 16, 2018 | Daily News

The House on Monday (July 16) passed an over-the-counter (OTC) monograph reform bill by voice vote that would amend FDA's OTC drug review process, set in place a user fee system known as OMUFA and grant 18 months of exclusivity to makers of innovative OTC drugs.

July 16, 2018 | Daily News

The House passed via voice vote on Monday (July 16) legislation to reauthorize FDA's animal drug and animal generic drug user fee programs.

July 16, 2018 | Daily News

A newly released draft FDA guidance says drug makers in certain circumstances can include in their Indications and Usage labeling an indication for an adult population in an age group broader than the population studied -- although the agency says this generally wouldn't apply across pediatric populations or between adult and pediatric populations because of statutory requirements.

July 16, 2018 | Daily News

FDA Commissioner Scott Gottlieb called for the creation of a national resource to coordinate the development and use of real-world evidence (RWE) in medical product development and regulatory science in a recent FDA Voice blog post.

July 13, 2018 | Daily News

Chronic pain patients, patient representatives and caregivers lambasted the Centers for Disease Control and Prevention’s opioid prescribing guidelines at an FDA meeting Monday (July 9), saying the guidelines have caused doctors to be reluctant to prescribe opioids and have led to patients being involuntarily weaned off much-needed medications.

July 13, 2018 | Daily News

The chronic pain patient community argued that policies to lower opioid prescribing rates are having a negative effect on patients, speaking at an FDA meeting Monday (July 9).

July 13, 2018 | Daily News

FDA will hold a two-day scientific conference in September to discuss how sex and gender influence opioid and tobacco misuse and abuse, the agency announced in the Federal Register Friday (July 13).

July 12, 2018 | Daily News

FDA defended its role in regulating cultured meats -- foods resembling meat, poultry and seafood that are produced using small amounts of cells from the animal that the food product is supposed to resemble -- during a public meeting held Thursday (July 12).

July 12, 2018 | Daily News

FDA published a suite of six gene therapy draft guidances on Wednesday (July 11) -- three of which are disease-specific while the other three focus on manufacturing and patient follow-ups -- following through on FDA Commissioner Scott Gottlieb's promise last year to issue the documents as part of a comprehensive policy to advance the field of gene therapy.

July 12, 2018 |

FDA has formed a Drug Shortages Task Force that will look into ways to prevent shortages of critical drugs, including reforming CMS and payor reimbursement policies, creating new financial incentives and expanding FDA's authority to require drug makers conduct shortage risk assessments, FDA Commissioner Scott Gottlieb announced Thursday (July 12).

July 12, 2018 | Daily News

FDA has formed a Drug Shortages Task Force that will look into ways to prevent shortages of critical drugs, including reforming CMS and payor reimbursement policies, creating new financial incentives and expanding FDA's authority to require drug makers conduct shortage risk assessments, FDA Commissioner Scott Gottlieb announced Thursday (July 12).

July 09, 2018 | Daily News

FDA and the United States Department of Agriculture are in dispute over which agency should regulate foods resembling meat, poultry and seafood that are produced using small amounts of cells from the animal that the food product is supposed to resemble.

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